K881094 is an FDA 510(k) clearance for the KOI(TM) BLADE GAUGE, MODEL KOI-132. This device is classified as a Caliper, Ophthalmic (Class I - General Controls, product code HOE).
Submitted by CooperVision, Inc. (Bellevue, US). The FDA issued a Cleared decision on April 1, 1988, 17 days after receiving the submission on March 15, 1988.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K881094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 1988 |
| Decision Date | April 01, 1988 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HOE — Caliper, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |