K140638 is an FDA 510(k) clearance for the PROPELLER SYSTEM - MODEL 2. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Reciprocal Labs Corporation (Madison, US). The FDA issued a Cleared decision on May 2, 2014, 51 days after receiving the submission on March 12, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K140638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2014 |
| Decision Date | May 02, 2014 |
| Days to Decision | 51 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 |