ANESTHESIOMETER
FDA 510(k) clearance K851557 · decided 1985-05-30
Clearance details
- K-number
- K851557
- Device name
- ANESTHESIOMETER
- Applicant
- Luneau SA
- Decision
- Substantially Equivalent
- Date received
- 1985-04-16
- Decision date
- 1985-05-30
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- HJC
- Device class
- 1
- Regulation number
- 886.1040
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chartres Cedex, FR
- 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 |
|---|---|---|
| WEINSTEIN CORNEAL MIRCOAESTHESIOMETER (K920271) | Connecticut Bioinstruments, Inc. | 1992-04-21 |
Recalls involving this device
No recalls on record reference this clearance.