GALIX MA-6C HOLTER CASSETTE RECORDER— 510(k) K904177

Name: FDA 510(k) clearance K904177
Creator: U.S. Food and Drug Administration
Published: 1991-09-20

Substantially Equivalent

Galix Instrumentacion Biomedica

FDA 510(k) clearance K904177 for GALIX MA-6C HOLTER CASSETTE RECORDER, Substantially Equivalent on 1991-09-20. Applicant: Galix Instrumentacion Biomedica. Device class: 2.

Clearance details

Applicant: Galix Instrumentacion Biomedica
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1990-09-11
Decision date: 1991-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buenos Aires, AR

Download summary PDF View on FDA.gov ↗

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K904176 — GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER1991-09-20

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.