BIOSYS FETAL MONITOR, MODEL IFM-500— 510(k) K994008

Substantially Equivalent

Biosys Co. , Ltd.

FDA 510(k) clearance K994008 for BIOSYS FETAL MONITOR, MODEL IFM-500, Substantially Equivalent on 2000-09-29. Applicant: Biosys Co. , Ltd..

Clearance details

Applicant: Biosys Co. , Ltd.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1999-11-24
Decision date: 2000-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, 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.