Cleared Traditional

Breezing Med

K200076 · Tf Health Co. · Anesthesiology
Sep 2020
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K200076 is an FDA 510(k) clearance for the Breezing Med, a Computer, Oxygen-uptake (Class II — Special Controls, product code BZL), submitted by Tf Health Co. (Tempe, US). The FDA issued a Cleared decision on September 25, 2020, 255 days after receiving the submission on January 14, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1730.

Submission Details

510(k) Number K200076 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2020
Decision Date September 25, 2020
Days to Decision 255 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZL — Computer, Oxygen-uptake
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1730