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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Oxygen-Uptake
510(k) Number K200076
Device Name Breezing Med
Applicant
TF Health Co.
1761 W. University Dr., Suite 140
Tempe,  AZ  85281
Applicant Contact Erik Herrmann
Correspondent
NDA Partners
1761 W. University Dr., Suite 140
Tempe,  AZ  85281
Correspondent Contact Roberta (Bobbi) Druyor-Sanchez
Regulation Number868.1730
Classification Product Code
BZL  
Date Received01/14/2020
Decision Date 09/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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