PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST

Spirometer, Monitoring (w/wo Alarm)

RESPIRONICS NOVAMETRIX, LLC

The following data is part of a premarket notification filed by Respironics Novametrix, Llc with the FDA for Philips Nm3 Respiratory Monitor With Ventassist.

Pre-market Notification Details

Device IDK103578
510k NumberK103578
Device Name:PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
ClassificationSpirometer, Monitoring (w/wo Alarm)
Applicant RESPIRONICS NOVAMETRIX, LLC 5 TECHNOLOGY DRIVE Wallingford,  CT  06492
ContactKevin Mader
CorrespondentKevin Mader
RESPIRONICS NOVAMETRIX, LLC 5 TECHNOLOGY DRIVE Wallingford,  CT  06492
Product CodeBZK  
CFR Regulation Number868.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-06
Decision Date2011-06-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838083363 K103578 000
00884838015616 K103578 000
00884838015630 K103578 000
00884838015647 K103578 000
00884838015654 K103578 000
00884838015678 K103578 000
00884838015685 K103578 000
00884838015692 K103578 000
00884838083349 K103578 000
00884838083356 K103578 000
00884838015593 K103578 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.