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510(k) K200076

Breezing Med by Tf Health Co. — Product Code BZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2020
Date Received
January 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Oxygen-Uptake
Device Class
Class II
Regulation Number
868.1730
Review Panel
AN
Submission Type

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