HOLTER ECG SCANNER— 510(k) K820014

Substantially Equivalent

Laser Scan Corp.

FDA 510(k) clearance K820014 for HOLTER ECG SCANNER, Substantially Equivalent on 1982-04-21. Applicant: Laser Scan Corp..

Clearance details

Applicant: Laser Scan Corp.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1982-01-05
Decision date: 1982-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.