The following data is part of a premarket notification filed by Hill-rom Services Private Limited with the FDA for The Vest Airway Clearance System.
Device ID | K142482 |
510k Number | K142482 |
Device Name: | The Vest Airway Clearance System |
Classification | Percussor, Powered-electric |
Applicant | Hill-Rom Services Private Limited 1 Yishum Avenue 7 Singapore, SG 768923 |
Contact | Christina Miracle |
Correspondent | Paul Dryden ProMedic, Inc. 24301 Woodsage Dr. Bonita Springs, FL 34134 |
Product Code | BYI |
CFR Regulation Number | 868.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-04 |
Decision Date | 2015-05-07 |
Summary: | summary |