K053248 is an FDA 510(k) clearance for the SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL. This device is classified as a Percussor, Powered-electric (Class II - Special Controls, product code BYI).
Submitted by Electromed, Inc. (Mahtomedi, US). The FDA issued a Cleared decision on December 1, 2005, 10 days after receiving the submission on November 21, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5665.
| 510(k) Number | K053248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2005 |
| Decision Date | December 01, 2005 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BYI - Percussor, Powered-electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5665 |