WOODLYN CLASSIC REFRACTOR, PHOROPTOR
FDA 510(k) clearance K874900 · decided 1987-12-23
Clearance details
- K-number
- K874900
- Device name
- WOODLYN CLASSIC REFRACTOR, PHOROPTOR
- Applicant
- Woodlyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-01
- Decision date
- 1987-12-23
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- HKN
- Device class
- 1
- Regulation number
- 886.1770
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Arlington Heights, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Woodlyn
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COMPREHENSIVE PHOROPTER, MDR-680 (K936205) | Canon USA, Inc. | 1994-09-28 |
| FUL-VUE (K782118) | American Optical Corp. | 1979-01-26 |
Recalls involving this device
No recalls on record reference this clearance.