K121587 is an FDA 510(k) clearance for the BREATH SHAKE. This device is classified as a Percussor, Powered-electric (Class II - Special Controls, product code BYI).
Submitted by Cheen Houng Ent. Co. , Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on November 22, 2013, 540 days after receiving the submission on May 31, 2012.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5665.
| 510(k) Number | K121587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2012 |
| Decision Date | November 22, 2013 |
| Days to Decision | 540 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 |