VKG 2000 VIDEO KERATOMETER
FDA 510(k) clearance K893968 · decided 1989-09-11
Clearance details
- K-number
- K893968
- Device name
- VKG 2000 VIDEO KERATOMETER
- Applicant
- Technitex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-02
- Decision date
- 1989-09-11
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- HJA
- Device class
- 1
- Regulation number
- 886.1350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Houston, TX, 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 |
| AMERICAN MEDICAL OPTICS PHOTOKERATO (K842128) | American Medical Optics | 1984-08-07 |
| DORC CONTACT/PHOTO DERATOSCOPE (K830290) | Jedmed Instrument Co. | 1983-03-09 |
| TERRY KERATOMETER (K781650) | Clifford M. Terry, M.C. | 1978-10-17 |
Recalls involving this device
No recalls on record reference this clearance.