NIDEK DIGITAL KERATOMETER
FDA 510(k) clearance K842892 · decided 1984-10-05
Clearance details
- K-number
- K842892
- Device name
- NIDEK DIGITAL KERATOMETER
- Applicant
- Nidek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-23
- Decision date
- 1984-10-05
- Days to decision
- 74 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 |
| AMER. MEDICAL OPTICS DIGITAL KERATO- (K842504) | American Medical Optics | 1984-10-01 |
| CILCO ANTERIOR CHAMBER LENS (K771933) | California Intraocular Lens | 1978-01-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S016) | Nidek, Inc. | 1990-03-13 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S015) | Nidek, Inc. | 1989-09-08 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S014) | Nidek, Inc. | 1989-08-30 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S012) | Nidek, Inc. | 1988-07-28 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S011) | Nidek, Inc. | 1987-06-11 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S009) | Nidek, Inc. | 1987-04-08 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S010) | Nidek, Inc. | 1986-12-01 |
| ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S007) | Nidek, Inc. | 1985-11-26 |