The following data is part of a premarket notification filed by Hill-rom Services Pte Ltd with the FDA for Monarch Airway Clearance System.
| Device ID | K163378 |
| 510k Number | K163378 |
| Device Name: | Monarch Airway Clearance System |
| Classification | Percussor, Powered-electric |
| Applicant | HILL-ROM SERVICES PTE LTD 1 YISHUN AVE 7 Singapore, SG |
| Contact | Huifang Zhu |
| Correspondent | Paul Dryden HILL-ROM SERVICES PTE LTD 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 | 2016-12-01 |
| Decision Date | 2017-03-17 |
| Summary: | summary |