510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K904177Substantially Equivalent

Galix Ma-6C Holter Cassette Recorder

Galix Instrumentacion Biomedica, Buenos Aires, AR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904177 is the FDA 510(k) clearance record for GALIX MA-6C HOLTER CASSETTE RECORDER, a class II device, cleared for Galix Instrumentacion Biomedica on under FDA product code DSH (Recorder, Magnetic Tape, Medical). FDA records list 2 510(k) clearances for Galix Instrumentacion Biomedica. As of , FDA records show no recalls naming K904177.

Clearance record

Decision date
Received
(374 days to decision)
Product code
DSH Recorder, Magnetic Tape, Medical
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Galix Instrumentacion Biomedica Rocamora 4029, Buenos Aires, AR
Third party review
No

Clearances, product code DSH

Trailing 12 months
3 clearances under product code DSH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260