Breezing Med

Computer, Oxygen-uptake

TF Health Co.

The following data is part of a premarket notification filed by Tf Health Co. with the FDA for Breezing Med.

Pre-market Notification Details

Device IDK200076
510k NumberK200076
Device Name:Breezing Med
ClassificationComputer, Oxygen-uptake
Applicant TF Health Co. 1761 W. University Dr., Suite 140 Tempe,  AZ  85281
ContactErik Herrmann
CorrespondentRoberta (bobbi) Druyor-sanchez
NDA Partners 1761 W. University Dr., Suite 140 Tempe,  AZ  85281
Product CodeBZL  
CFR Regulation Number868.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-14
Decision Date2020-09-25

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