AMER. MEDICAL OPTICS DIGITAL KERATO-
FDA 510(k) clearance K842504 · decided 1984-10-01
Clearance details
- K-number
- K842504
- Device name
- AMER. MEDICAL OPTICS DIGITAL KERATO-
- Applicant
- American Medical Optics
- Decision
- Substantially Equivalent
- Date received
- 1984-06-26
- Decision date
- 1984-10-01
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- HQL
- Device class
- 3
- Regulation number
- 886.3600
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Walker, MI, 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 |
|---|---|---|
| CHIROFLEX II LENS MICROSERT(TM) (K914311) | Chiron Ophthalmics | 1992-01-27 |
| SOFTRANS INJECTOR (K913626) | Staar Surgical Co. | 1991-12-18 |
| NIDEK DIGITAL KERATOMETER (K842892) | Nidek, Inc. | 1984-10-05 |
| CILCO ANTERIOR CHAMBER LENS (K771933) | California Intraocular Lens | 1978-01-26 |
Recalls involving this device
No recalls on record reference this clearance.