K791105 is an FDA 510(k) clearance for the B & L OPHTHALMIC CHAIR. This device is classified as a Stand, Instrument, Ac-powered, Ophthalmic (Class I - General Controls, product code HMF).
Submitted by Bausch & Lomb, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 24, 1979, 41 days after receiving the submission on June 13, 1979.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1860.
| 510(k) Number | K791105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 1979 |
| Decision Date | July 24, 1979 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | HMF - Stand, Instrument, Ac-powered, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1860 |