OMF-7101 FETAL MONITOR— 510(k) K860237

Substantially Equivalent

Nihon Kohden America, Inc.

FDA 510(k) clearance K860237 for OMF-7101 FETAL MONITOR, Substantially Equivalent on 1986-09-05. Applicant: Nihon Kohden America, Inc..

Clearance details

Applicant: Nihon Kohden America, Inc.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1986-01-23
Decision date: 1986-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.