K844250 is an FDA 510(k) clearance for the OSADA ENAC. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Osada Electric Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on January 23, 1985, 82 days after receiving the submission on November 2, 1984.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K844250 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1984 |
| Decision Date | January 23, 1985 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | ELC — Scaler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4850 |