HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER— 510(k) K950004

Substantially Equivalent

Aerotel, Ltd.

FDA 510(k) clearance K950004 for HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER, Substantially Equivalent on 1995-10-24. Applicant: Aerotel, Ltd..

Clearance details

Applicant: Aerotel, Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1995-01-03
Decision date: 1995-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

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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.