Aer X

Generator, Oxygen, Portable

3B Medical Inc.

The following data is part of a premarket notification filed by 3b Medical Inc. with the FDA for Aer X.

Pre-market Notification Details

Device IDK200496
510k NumberK200496
Device Name:Aer X
ClassificationGenerator, Oxygen, Portable
Applicant 3B Medical Inc. 203 Avenue A NW, Suite 300 Winter Haven,  FL  33881
ContactYasser Estafanous
CorrespondentYasser Estafanous
3B Medical Inc. 203 Avenue A NW, Suite 300 Winter Haven,  FL  33881
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-28
Decision Date2020-07-24

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