CARDIART 108T/313— 510(k) K761014

Substantially Equivalent

Conway Electronic Enterprises , Ltd.

FDA 510(k) clearance K761014 for CARDIART 108T/313, Substantially Equivalent on 1976-12-06. Applicant: Conway Electronic Enterprises , Ltd..

Clearance details

Applicant: Conway Electronic Enterprises , Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1976-11-09
Decision date: 1976-12-06
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.