ECHO-CARDIOTRACE, AUTOMATIC— 510(k) K761201

Substantially Equivalent

Metrix Co.

FDA 510(k) clearance K761201 for ECHO-CARDIOTRACE, AUTOMATIC, Substantially Equivalent on 1977-01-12. Applicant: Metrix Co..

Clearance details

Applicant: Metrix Co.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1976-12-06
Decision date: 1977-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

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.