CARDIOCAP DR-124 RECORDER— 510(k) K910620

Name: FDA 510(k) clearance K910620
Creator: U.S. Food and Drug Administration
Published: 1991-05-07

Substantially Equivalent

Datex Division Instrumentarium Corp.

FDA 510(k) clearance K910620 for CARDIOCAP DR-124 RECORDER, Substantially Equivalent on 1991-05-07. Applicant: Datex Division Instrumentarium Corp.. Device class: 2.

Clearance details

Applicant: Datex Division Instrumentarium Corp.
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 1991-02-12
Decision date: 1991-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, Finland, FI

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.