SYSTEMS INTEGRATION MODEL: ENDOALPHA— 510(k) K100345
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K100345 for SYSTEMS INTEGRATION MODEL: ENDOALPHA, Substantially Equivalent on 2010-03-22. Applicant: Olympus Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Code ODA
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Center Valley, PA, US
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