510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001743Substantially Equivalent

Ultima Smartbelt, Model 0560

Braebon Medical Corp., Carp, Ontario, CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K001743 is the FDA 510(k) clearance record for ULTIMA SMARTBELT, MODEL 0560, a class II device, cleared for Braebon Medical Corp. on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list 8 510(k) clearances for Braebon Medical Corp., from to . As of , FDA records show no recalls naming K001743.

Clearance record

Decision date
Received
(78 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Braebon Medical Corp. 120 Walgreen Dr. (Rr#3), Carp, Ontario, CA
510(k) summary
Statement
Third party review
No

Clearances, product code BZQ

Trailing 12 months
2 clearances under product code BZQ in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260