3 CHANNEL DIGITAL AMBULATORY ECG RECORDER— 510(k) K971670

Substantially Equivalent

Galix Biomedical Instrumentation, Inc.

FDA 510(k) clearance K971670 for 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER, Substantially Equivalent on 1998-01-29. Applicant: Galix Biomedical Instrumentation, Inc..

Clearance details

Applicant: Galix Biomedical Instrumentation, Inc.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1997-05-06
Decision date: 1998-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

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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.