WEINSTEIN CORNEAL MIRCOAESTHESIOMETER
FDA 510(k) clearance K920271 · decided 1992-04-21
Clearance details
- K-number
- K920271
- Device name
- WEINSTEIN CORNEAL MIRCOAESTHESIOMETER
- Applicant
- Connecticut Bioinstruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-01-22
- Decision date
- 1992-04-21
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HJC
- Device class
- 1
- Regulation number
- 886.1040
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Danbury, CT, 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 |
|---|---|---|
| ANESTHESIOMETER (K851557) | Luneau SA | 1985-05-30 |
Recalls involving this device
No recalls on record reference this clearance.