K822625 is an FDA 510(k) clearance for the SYNTEVENT ATOMIZER/NEBULIZER AEROSOL. This device is classified as a Nebulizer, Medicinal, Non-ventilatory (atomizer) (Class I - General Controls, product code CCQ).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1982, 44 days after receiving the submission on August 30, 1982.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5640.
| 510(k) Number | K822625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 1982 |
| Decision Date | October 13, 1982 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCQ — Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5640 |