The Vest Airway Clearance System

Percussor, Powered-electric

Hill-Rom Services Private Limited

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.

Pre-market Notification Details

Device IDK142482
510k NumberK142482
Device Name:The Vest Airway Clearance System
ClassificationPercussor, Powered-electric
Applicant Hill-Rom Services Private Limited 1 Yishum Avenue 7 Singapore,  SG 768923
ContactChristina Miracle
CorrespondentPaul Dryden
ProMedic, Inc. 24301 Woodsage Dr. Bonita Springs,  FL  34134
Product CodeBYI  
CFR Regulation Number868.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-04
Decision Date2015-05-07
Summary:summary

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