510(k) K142482
K142482 is an FDA 510(k) premarket notification submitted by Hill-Rom Services Private Limited for the device "The Vest Airway Clearance System". The FDA issued a decision of Substantially Equivalent on May 7, 2015. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2015
- Date Received
- September 4, 2014
- 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