K091272 is an FDA 510(k) clearance for the BESMED JET NEBULIZER BOTTLE SET. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Besmed Health Business Corp (Hsin Chu City, TW). The FDA issued a Cleared decision on November 10, 2009, 194 days after receiving the submission on April 30, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K091272 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2009 |
| Decision Date | November 10, 2009 |
| Days to Decision | 194 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 |