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2024/4/9 11:04 44258 F510YY 001-0.0_前言.docx
2024/4/9 11:04 6801080 F510YY 001-1.0 eSTAR填写版参考模板.pdf
2024/4/9 11:04 26274 F510YY 001-2.0_0 Application Submission Type.docx
2024/4/9 11:04 25083 F510YY 001-2.0_1 Cover Letter Letters of Reference.docx
2024/4/9 11:04 35825 F510YY 001-2.0_1-1 Attach your Cover Letter.docx
2024/4/9 11:04 23838 F510YY 001-2.0_1-2 Attach any Letters of Reference.docx
2024/4/9 11:04 41003 F510YY 001-2.0_10 Software Firmware & Cybersecurity Interoperability.docx
2024/4/9 11:04 31818 F510YY 001-2.0_10-1 Software Description.docx
2024/4/9 11:04 28760 F510YY 001-2.0_10-10 Unresolved Anomalies.docx
2024/4/9 11:04 84282 F510YY 001-2.0_10-11 Risk Management.docx
2024/4/9 11:04 23410 F510YY 001-2.0_10-12 Cybersecurity Management Plan.docx
2024/4/9 11:04 24473 F510YY 001-2.0_10-13 Interoperability Risk Assessment Verification and Validation.docx
2024/4/9 11:04 40303 F510YY 001-2.0_10-2 Device Hazard Analysis.docx
2024/4/9 11:04 33250 F510YY 001-2.0_10-3 Software Requirements Specifications (SRS).docx
2024/4/9 11:04 30145 F510YY 001-2.0_10-4 Architecture Design Chart.docx
2024/4/9 11:04 28746 F510YY 001-2.0_10-5 Software Design Specifications (SDS).docx
2024/4/9 11:04 31197 F510YY 001-2.0_10-6 Traceability AnalysisMatrix.docx
2024/4/9 11:04 40121 F510YY 001-2.0_10-7 Software Development EnvironmentLife Cycle Process Description.docx
2024/4/9 11:04 29786 F510YY 001-2.0_10-8 Verification & Validation Testing.docx
2024/4/9 11:04 27774 F510YY 001-2.0_10-9 Revision Level History.docx
2024/4/9 11:04 42598 F510YY 001-2.0_11 EMC, Wireless, Electrical, Mechanical, and Thermal Safety.docx
2024/4/9 11:04 23309 F510YY 001-2.0_11-1 EMC Emissions and Immunity Test Information.docx
2024/4/9 11:04 23964 F510YY 001-2.0_11-2 Modifications.docx
2024/4/9 11:04 23177 F510YY 001-2.0_11-3 Coexistence Testing.docx
2024/4/9 11:04 23303 F510YY 001-2.0_11-4 Electromagnetic Compatibility testing.docx
2024/4/9 11:04 23526 F510YY 001-2.0_11-5 Safeguards.docx
2024/4/9 11:04 23537 F510YY 001-2.0_11-6 Wireless Testing.docx
2024/4/9 11:04 23507 F510YY 001-2.0_11-7 Electrical, Mechanical and Thermal Testing.docx
2024/4/9 11:04 34519 F510YY 001-2.0_12 Performance Testing.docx
2024/4/9 11:04 28452 F510YY 001-2.0_12-1 Bench Testing.docx
2024/4/9 11:04 23744 F510YY 001-2.0_12-2 Animal Testing report.docx
2024/4/9 11:04 23704 F510YY 001-2.0_12-3 Clinical test report.docx
2024/4/9 11:04 24038 F510YY 001-2.0_13 References.docx
2024/4/9 11:04 23199 F510YY 001-2.0_13-1 Summary of literature referenced.docx
2024/4/9 11:04 26936 F510YY 001-2.0_14 Administrative Documentation.docx
2024/4/9 11:04 33491 F510YY 001-2.0_14-1 Executive Summary.docx
2024/4/9 11:04 730640 F510YY 001-2.0_14-2-1 Financial Certification.pdf
2024/4/9 11:04 24994 F510YY 001-2.0_14-2-2 Disclosure Statement.docx
2024/4/9 11:04 3486401 F510YY 001-2.0_14-3 Clinical Trials Certification Form.pdf
2024/4/9 11:04 24535 F510YY 001-2.0_14-4 Truthful and Accurate statement.docx
2024/4/9 11:04 34256 F510YY 001-2.0_14-5 510(k) Summary or Statement.docx
2024/4/9 11:04 23915 F510YY 001-2.0_14-6 User Fee form.docx
2024/4/9 11:04 26935 F510YY 001-2.0_2 Administrative Information.docx
2024/4/9 11:04 23695 F510YY 001-2.0_2-1 Pre-submission correspondence.docx
2024/4/9 11:04 23581 F510YY 001-2.0_2-2 Standards Details Supplemental Documentation.docx
2024/4/9 11:04 36315 F510YY 001-2.0_3 Device Description.docx
2024/4/9 11:04 30499 F510YY 001-2.0_3-1 Comprehensive Device Description and Principles of Operation Documentation.docx
2024/4/9 11:04 23847 F510YY 001-2.0_3-2 Device Pictures, Illustrations, Schematics, Diagrams.docx
2024/4/9 11:04 23645 F510YY 001-2.0_3-3 Description of Device Packaging.docx
2024/4/9 11:04 23514 F510YY 001-2.0_3-4 SystemKit Component 1.docx
2024/4/9 11:04 24527 F510YY 001-2.0_3-5 SystemKit Component 2.docx
2024/4/9 11:04 24624 F510YY 001-2.0_3-6 SystemKit Component 3.docx
2024/4/9 11:04 23148 F510YY 001-2.0_4 Indications for Use.docx
2024/4/9 11:04 27285 F510YY 001-2.0_5 Classification.docx
2024/4/9 11:04 27498 F510YY 001-2.0_6 Predicates and Substantial Equivalence.docx
2024/4/9 11:04 29692 F510YY 001-2.0_6-1 Substantial Equivalence Comparison.docx
2024/4/9 11:04 39052 F510YY 001-2.0_7 Labeling.docx
2024/4/9 11:04 166156 F510YY 001-2.0_7-1 Package Label.docx
2024/4/9 11:04 24004 F510YY 001-2.0_7-2 Instructions for Use.docx
2024/4/9 11:04 23498 F510YY 001-2.0_7-3 Other Labeling.docx
2024/4/9 11:04 37508 F510YY 001-2.0_8 Reprocessing, Sterility, and Shelf-Life.docx
2024/4/9 11:04 23588 F510YY 001-2.0_8-1 Reprocessing validation report.docx
2024/4/9 11:04 23627 F510YY 001-2.0_8-2 Sterilization validation.docx
2024/4/9 11:04 56197 F510YY 001-2.0_8-3 Shelf-Life test report.docx
2024/4/9 11:04 23384 F510YY 001-2.0_8-4 Package Validation.docx
2024/4/9 11:04 33420 F510YY 001-2.0_9 Biocompatibility.docx
2024/4/9 11:04 23726 F510YY 001-2.0_9-1 Biocompatibility Reports and Documentation.docx