BLADE GAUGE
FDA 510(k) clearance K812011 · decided 1981-07-28
Clearance details
- K-number
- K812011
- Device name
- BLADE GAUGE
- Applicant
- Koi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-07-17
- Decision date
- 1981-07-28
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- HOE
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| KOI(TM) BLADE GAUGE, MODEL KOI-132 (K881094) | CooperVision, Inc. | 1988-04-01 |
| CALIPER-OPTHALMIC (K813315) | Design Research Assoc., Inc. | 1982-03-01 |
| KREMER BLADE GAUGE (K820050) | Accutome, Inc. | 1982-02-24 |
| BLEPHAROMETER (K801937) | Aztec Medical Products, Inc. | 1980-09-16 |
| KELMAN DIPSTICK (K792383) | V. Mueller O.V. Baxter Healthcare Corp. | 1979-12-11 |
| RULER, WECK SCOTT (K781715) | Edward Weck, Inc. | 1978-12-04 |
Recalls involving this device
No recalls on record reference this clearance.