NxtGen Infant Transport Incubator

Incubator, Neonatal Transport

International Biomedical

The following data is part of a premarket notification filed by International Biomedical with the FDA for Nxtgen Infant Transport Incubator.

Pre-market Notification Details

Device IDK220742
510k NumberK220742
Device Name:NxtGen Infant Transport Incubator
ClassificationIncubator, Neonatal Transport
Applicant International Biomedical 8206 Cross Park Drive Austin,  TX  78754
ContactAmy Pieper
CorrespondentAmy Pieper
International Biomedical 8206 Cross Park Drive Austin,  TX  78754
Product CodeFPL  
CFR Regulation Number880.5410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-14
Decision Date2022-07-15

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