TERRY KERATOMETER
FDA 510(k) clearance K781650 · decided 1978-10-17
Clearance details
- K-number
- K781650
- Device name
- TERRY KERATOMETER
- Applicant
- Clifford M. Terry, M.C.
- Decision
- Substantially Equivalent
- Date received
- 1978-09-27
- Decision date
- 1978-10-17
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- HJA
- Device class
- 1
- Regulation number
- 886.1350
- 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 |
|---|---|---|
| VKG 1000, VIDEO KERATOGRAPH (K901523) | The Sanborn Co. | 1990-06-27 |
| VKG 2000 VIDEO KERATOMETER (K893968) | Technitex, Inc. | 1989-09-11 |
| AMERICAN MEDICAL OPTICS PHOTOKERATO (K842128) | American Medical Optics | 1984-08-07 |
| DORC CONTACT/PHOTO DERATOSCOPE (K830290) | Jedmed Instrument Co. | 1983-03-09 |
Recalls involving this device
No recalls on record reference this clearance.