200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM
FDA 510(k) clearance K944759 · decided 1995-04-11
Clearance details
- K-number
- K944759
- Device name
- 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM
- Applicant
- Fujinon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-27
- Decision date
- 1995-04-11
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- FET
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Wayne, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures. recall (Z-2805-2015) | Fujifilm Medical Systems U.S.A., Inc. | 2015-09-22 |
| Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endosc recall (Z-2806-2015) | Fujifilm Medical Systems U.S.A., Inc. | 2015-09-22 |