PHILIPS NM3 MONITOR, MODEL 7900

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 Monitor, Model 7900.

Pre-market Notification Details

Device IDK091459
510k NumberK091459
Device Name:PHILIPS NM3 MONITOR, MODEL 7900
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-18
Decision Date2009-07-28
Summary:summary

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