K883964 is an FDA 510(k) clearance for the AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on November 30, 1988, 71 days after receiving the submission on September 20, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K883964 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 1988 |
| Decision Date | November 30, 1988 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAF — Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |