VKG 1000, VIDEO KERATOMETER
FDA 510(k) clearance K883471 · decided 1988-11-08
Clearance details
- K-number
- K883471
- Device name
- VKG 1000, VIDEO KERATOMETER
- Applicant
- Technitex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-16
- Decision date
- 1988-11-08
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- HLP
- Device class
- 1
- Regulation number
- 886.1880
- 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 |
|---|---|---|
| THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT. (K874250) | Richmond Products, Inc. | 1988-01-11 |
| WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT (K874251) | Richmond Products, Inc. | 1988-01-11 |
Recalls involving this device
No recalls on record reference this clearance.