K760770 is an FDA 510(k) clearance for the SOLA COMMIDO LOUPE. This device is classified as a Ophthalmoscope, Battery-powered (Class II - Special Controls, product code HLJ).
Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 15, 1976, 11 days after receiving the submission on October 4, 1976.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K760770 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1976 |
| Decision Date | October 15, 1976 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | HLJ - Ophthalmoscope, Battery-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |