K080230 is an FDA 510(k) clearance for the NEB-U-MASK SYSTEM, MODELS 1895, 1896. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Teleflexmedical, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on June 9, 2008, 131 days after receiving the submission on January 30, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K080230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2008 |
| Decision Date | June 09, 2008 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAF — Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |