510(k) K163378
K163378 is an FDA 510(k) premarket notification submitted by Hill-Rom Services Pte, Ltd. for the device "Monarch Airway Clearance System". The FDA issued a decision of Substantially Equivalent on March 17, 2017. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. Hill-Rom Services Pte, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2017
- Date Received
- December 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Percussor, Powered-Electric
- Device Class
- Class II
- Regulation Number
- 868.5665
- Review Panel
- AN
- Submission Type