510(k) K163378 ยท BYI Percussor, Powered-Electric
Monarch Airway Clearance System
| Applicant | Hill-Rom Services Pte, Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Mar 17, 2017 |
| Received | Dec 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163378
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2017 | HILL-ROM MANUFACTURING, INC. Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Terminated |
BYI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.