LOFLO C5 CO2 SENSOR

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

RESPIRONICS NOVAMETRIX LLC

The following data is part of a premarket notification filed by Respironics Novametrix Llc with the FDA for Loflo C5 Co2 Sensor.

Pre-market Notification Details

Device IDK053174
510k NumberK053174
Device Name:LOFLO C5 CO2 SENSOR
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant RESPIRONICS NOVAMETRIX LLC 5 TECHNOLOGY DRIVE Wallingford,  CT  06492
ContactKevin Mader
CorrespondentKevin Mader
RESPIRONICS NOVAMETRIX LLC 5 TECHNOLOGY DRIVE Wallingford,  CT  06492
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-14
Decision Date2006-01-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838084681 K053174 000
00884838082304 K053174 000
00884838082298 K053174 000
00884838082281 K053174 000
00884838074736 K053174 000
00884838013681 K053174 000

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