PHOTOGRAPHIC EQUIPMENT
FDA 510(k) clearance K812201 · decided 1981-10-19
Clearance details
- K-number
- K812201
- Device name
- PHOTOGRAPHIC EQUIPMENT
- Applicant
- Reznik Instruments
- Decision
- Substantially Equivalent
- Date received
- 1981-08-04
- Decision date
- 1981-10-19
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- FEM
- Device class
- 1
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| CAMERA COVER WITH TEAR TIP (K940152) | Hydro-Med Products, Inc. | 1994-10-28 |
| POLAROID INSTANT ENDOCAMERA (K812542) | Polaroid Corp. | 1981-10-19 |
| POLAROID LAND CAMERA FOR ENDOSCOPY (K792512) | Polaroid Corp. | 1979-12-20 |
Recalls involving this device
No recalls on record reference this clearance.