InfaTherm Disposable Infant Warming Mattress

Pack, Hot Or Cold, Disposable

International Biomedical

The following data is part of a premarket notification filed by International Biomedical with the FDA for Infatherm Disposable Infant Warming Mattress.

Pre-market Notification Details

Device IDK221653
510k NumberK221653
Device Name:InfaTherm Disposable Infant Warming Mattress
ClassificationPack, Hot Or Cold, Disposable
Applicant International Biomedical 8206 Cross Park Drive Austin,  TX  78754
ContactAmy Pieper
CorrespondentAmy Pieper
International Biomedical 8206 Cross Park Drive Austin,  TX  78754
Product CodeIMD  
CFR Regulation Number890.5710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-07
Decision Date2022-10-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850018561587 K221653 000

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