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
10884521084575 K123083 000

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