The following data is part of a premarket notification filed by Hill-rom Holdings, Inc. with the FDA for Monarch Airway Clearance System.
| Device ID | K173603 |
| 510k Number | K173603 |
| Device Name: | Monarch Airway Clearance System |
| Classification | Percussor, Powered-electric |
| Applicant | Hill-Rom Holdings, Inc. 1 Yishun Ave 7 Singapore, SG |
| Contact | Joseph Braido |
| Correspondent | Paul Dryden Hill-Rom Holdings, Inc. 1 Yishun Ave 7 Singapore, SG |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-21 |
| Decision Date | 2018-10-24 |
| Summary: | summary |