K163378 is an FDA 510(k) clearance for the Monarch Airway Clearance System. This device is classified as a Percussor, Powered-electric (Class II - Special Controls, product code BYI).
Submitted by Hill-Rom Services Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on March 17, 2017, 106 days after receiving the submission on December 1, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5665.
| 510(k) Number | K163378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2016 |
| Decision Date | March 17, 2017 |
| Days to Decision | 106 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 |