CG-900P FETAL/MATERNAL MONITOR— 510(k) K010552

Substantially Equivalent

Card Guard Scientific Survival , Ltd.

FDA 510(k) clearance K010552 for CG-900P FETAL/MATERNAL MONITOR, Substantially Equivalent on 2001-05-11. Applicant: Card Guard Scientific Survival , Ltd..

Clearance details

Applicant: Card Guard Scientific Survival , Ltd.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2001-02-26
Decision date: 2001-05-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Rehovot, IL

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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.