K823134 is an FDA 510(k) clearance for the AIR FLOW II. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Healthco, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 17, 1982, 23 days after receiving the submission on October 25, 1982.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K823134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1982 |
| Decision Date | November 17, 1982 |
| Days to Decision | 23 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 |