ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE— 510(k) K771645

Substantially Equivalent

Tronomed, Inc.

FDA 510(k) clearance K771645 for ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE, Substantially Equivalent on 1977-10-18. Applicant: Tronomed, Inc..

Clearance details

Applicant: Tronomed, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 1977-08-29
Decision date: 1977-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.