510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092853Substantially Equivalent

3 Channel Digital Ambulatory ECG Recorder Model Galix Gbi-3Sm

Galix Biomedical Instrumentation, Inc., Miami Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K092853 is the FDA 510(k) clearance record for 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM, a class II device, cleared for Galix Biomedical Instrumentation, Inc. on under FDA product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm). FDA records list 6 510(k) clearances for Galix Biomedical Instrumentation, Inc., from to . As of , FDA records show no recalls naming K092853.

Clearance record

Decision date
Received
(296 days to decision)
Product code
MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Galix Biomedical Instrumentation, Inc. 2555 Collins Ave., C-5, Miami Beach FL
510(k) summary
Statement
Third party review
No

Clearances, product code MLO

Trailing 12 months
1 clearance under product code MLO in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MLO, 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 20261
October 20260