K935945 is an FDA 510(k) clearance for the ROTA DATAMATE I. This device is classified as a Stand, Instrument, Ac-powered, Ophthalmic (Class I - General Controls, product code HMF).
Submitted by Rota Systems,Inc. (Derby, US). The FDA issued a Cleared decision on April 19, 1994, 127 days after receiving the submission on December 13, 1993.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1860.
| 510(k) Number | K935945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1993 |
| Decision Date | April 19, 1994 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HMF — Stand, Instrument, Ac-powered, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1860 |