COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT

System, Thermal Regulating

COVIDIEN

The following data is part of a premarket notification filed by Covidien with the FDA for Covidien Warmtouch Convective Warming Unit.

Pre-market Notification Details

Device IDK123083
510k NumberK123083
Device Name:COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
ClassificationSystem, Thermal Regulating
Applicant COVIDIEN 6135 GUNBARREL AVE. Boulder,  CO  80301
ContactStacey A Strand
CorrespondentStacey A Strand
COVIDIEN 6135 GUNBARREL AVE. Boulder,  CO  80301
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-01
Decision Date2013-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521084599 K123083 000
10884521084568 K123083 000
10884521141100 K123083 000
10884521190672 K123083 000
10884521817517 K123083 000
10884521084612 K123083 000
10884521169227 K123083 000
10884521817524 K123083 000

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