HEWLETT-PACKARD MODEL M1351A FETAL MONITOR— 510(k) K921957

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K921957 for HEWLETT-PACKARD MODEL M1351A FETAL MONITOR, Substantially Equivalent on 1993-09-24. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1992-04-27
Decision date: 1993-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Germany, DE

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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.