OXFORD OPTRONIX MPM 3S
FDA 510(k) clearance K914397 · decided 1992-11-16
Clearance details
- K-number
- K914397
- Device name
- OXFORD OPTRONIX MPM 3S
- Applicant
- Dia-Stron, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-01
- Decision date
- 1992-11-16
- Days to decision
- 412 days
- Clearance type
- Traditional
- Product code
- FTI
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Broomall, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CLARUS MODEL 5197 SIGHTLITE (K971455) | Clarus Medical Systems, Inc. | 1997-05-20 |
Recalls involving this device
No recalls on record reference this clearance.