LS6 ARRYTHMIA DISCRIMINATOR— 510(k) K822616

Name: FDA 510(k) clearance K822616
Creator: U.S. Food and Drug Administration
Published: 1982-10-18

Substantially Equivalent

Life Science Instrumentation, Inc.

FDA 510(k) clearance K822616 for LS6 ARRYTHMIA DISCRIMINATOR, Substantially Equivalent on 1982-10-18. Applicant: Life Science Instrumentation, Inc.. Device class: 2.

Clearance details

Applicant: Life Science Instrumentation, Inc.
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1982-08-30
Decision date: 1982-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Life Science Instrumentation, Inc.

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K850812 — EMERGIPACE - EXTERNAL PACEMAKER1985-11-05
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K843396 — LS-260G MONITOR/RECORDER & DEFIBILLATOR1984-10-19
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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.