MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM— 510(k) K942887

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K942887 for MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM, Substantially Equivalent on 1994-08-15. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1994-06-20
Decision date: 1994-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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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.