COMPREHENSIVE PHOROPTER, MDR-680
FDA 510(k) clearance K936205 · decided 1994-09-28
Clearance details
- K-number
- K936205
- Device name
- COMPREHENSIVE PHOROPTER, MDR-680
- Applicant
- Canon USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-29
- Decision date
- 1994-09-28
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- HKN
- Device class
- 1
- Regulation number
- 886.1770
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Lake Success, NY, 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 |
|---|---|---|
| WOODLYN CLASSIC REFRACTOR, PHOROPTOR (K874900) | Woodlyn, Inc. | 1987-12-23 |
| FUL-VUE (K782118) | American Optical Corp. | 1979-01-26 |
Recalls involving this device
No recalls on record reference this clearance.