MetaNeb 4 System

Device, Positive Pressure Breathing, Intermittent

Hill-Rom Services Pte Ltd

The following data is part of a premarket notification filed by Hill-rom Services Pte Ltd with the FDA for Metaneb 4 System.

Pre-market Notification Details

Device IDK151689
510k NumberK151689
Device Name:MetaNeb 4 System
ClassificationDevice, Positive Pressure Breathing, Intermittent
Applicant Hill-Rom Services Pte Ltd 1 Yishun Ave 7 Singapore,  SG 768923
ContactHuifang Zhu
CorrespondentPaul Dryden
Hill-Rom Services Pte Ltd 1 Yishun Ave 7 Singapore,  SG 768923
Product CodeNHJ  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-23
Decision Date2016-03-17
Summary:summary

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