FLEXIBLE FIBER OPTIC ENDOSCOPE
FDA 510(k) clearance K922826 · decided 1993-02-19
Clearance details
- K-number
- K922826
- Device name
- FLEXIBLE FIBER OPTIC ENDOSCOPE
- Applicant
- Optimed Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-11
- Decision date
- 1993-02-19
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- FGA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Orange, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Access Immunoassay Systems, Part Number 81600N & 81600N. An in vitro diagnostic device use recall (Z-1935-2011) | Beckman Coulter Inc. | 2011-04-12 |