BIOSENSOR HOLTER MONITOR SYSTEM— 510(k) K974546

Name: FDA 510(k) clearance K974546
Creator: U.S. Food and Drug Administration
Published: 1998-03-04

Substantially Equivalent

Biosensor Corp.

FDA 510(k) clearance K974546 for BIOSENSOR HOLTER MONITOR SYSTEM, Substantially Equivalent on 1998-03-04. Applicant: Biosensor Corp.. Device class: 2.

Clearance details

Applicant: Biosensor Corp.
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 1997-12-04
Decision date: 1998-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Biosensor Corp.

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K990956 — BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 10051999-06-14
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K950944 — AMBULATORY (HOLTER) RECORDING SYSTEM1996-06-18
K960449 — PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)1996-05-30
K943338 — BIOSENSOR BIDOP VASCULAR TEST SYSTEM1996-04-12

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.