TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER— 510(k) K021574

Substantially Equivalent

Card Guard Scientific Survival , Ltd.

FDA 510(k) clearance K021574 for TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER, Substantially Equivalent on 2002-08-12. Applicant: Card Guard Scientific Survival , Ltd..

Clearance details

Applicant: Card Guard Scientific Survival , Ltd.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2002-05-14
Decision date: 2002-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot, IL

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.