MACULAR FUNCTION ANALYZER
FDA 510(k) clearance K843227 · decided 1985-07-22
Clearance details
- K-number
- K843227
- Device name
- MACULAR FUNCTION ANALYZER
- Applicant
- Danek Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-16
- Decision date
- 1985-07-22
- Days to decision
- 340 days
- Clearance type
- Traditional
- Product code
- HOQ
- Device class
- 1
- Regulation number
- 886.1330
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Danek Medical
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 |
|---|---|---|
| Alleye (K180895) | Oculocare Medical AG | 2018-06-27 |
| myVision Track Model 005 (K143211) | Vital Art and Science Incorporated | 2015-03-20 |
| MYVISIONTRACK(TM) (K121738) | Vital Art and Science Incorporated | 2013-02-22 |
| MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) (K014044) | Notal Vision, Inc. | 2002-03-04 |
| KREDA DISC (K874252) | Richmond Products, Inc. | 1988-01-27 |
| MODIFIED DEVICE FOR SELF EXAMINATION OF EYES (K863429) | Wheel Checkers | 1987-01-20 |
| APPARATUS & METHODS SELF-EXAM OF EYE (K843702) | Wheel Checkers | 1985-01-03 |
Recalls involving this device
No recalls on record reference this clearance.