510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200076Substantially Equivalent

Breezing Med

TF Health Corp., Tempe AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200076 is the FDA 510(k) clearance record for Breezing Med, a class II device, cleared for Tf Health Co. on under FDA product code BZL (Computer, Oxygen-Uptake). FDA records list one 510(k) clearance for Tf Health Co. As of , FDA records show no recalls naming K200076.

Clearance record

Decision date
Received
(255 days to decision)
Product code
BZL Computer, Oxygen-Uptake
Regulation
21 CFR 868.1730
Device class
Class II
Review panel
Anesthesiology
Applicant
Tf Health Co. 1761 W University Dr. Suite 140, Tempe AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZL

Trailing 12 months

FDA records hold no clearances under product code BZL in the trailing twelve months.

FDA records show no clearances under product code BZL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260