510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812045Substantially Equivalent

Infant Apnea Monitor Model 100

Medix Medical Electronics (U.S.A.), Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812045 is the FDA 510(k) clearance record for INFANT APNEA MONITOR MODEL 100, a class II device, cleared for Medix Medical Electronics (U.S.A.), Inc. on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list 14 510(k) clearances for Medix Medical Electronics (U.S.A.), Inc., from to . As of , FDA records show no recalls naming K812045.

Clearance record

Decision date
Received
(65 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Medix Medical Electronics (U.S.A.), Inc. 803 N. Front St. Suite 3, Mchenry IL
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