K812896 is an FDA 510(k) clearance for the I.V.E. REFRACTION SYSTEM. This device is classified as a Refractometer, Ophthalmic (Class I - General Controls, product code HKO).
Submitted by Bausch & Lomb, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1981, 48 days after receiving the submission on October 15, 1981.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1760.
| 510(k) Number | K812896 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1981 |
| Decision Date | December 02, 1981 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | HKO - Refractometer, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1760 |