UROVIEW 2800
FDA 510(k) clearance K993687 · decided 1999-12-21
Clearance details
- K-number
- K993687
- Device name
- UROVIEW 2800
- Applicant
- Ge Dec Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1999-11-01
- Decision date
- 1999-12-21
- Days to decision
- 50 days
- Clearance type
- Abbreviated
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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