OB-1 FETAL MONITOR— 510(k) K011304

Substantially Equivalent

Analogic Corp.

FDA 510(k) clearance K011304 for OB-1 FETAL MONITOR, Substantially Equivalent on 2001-05-29. Applicant: Analogic Corp..

Clearance details

Applicant: Analogic Corp.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2001-04-30
Decision date: 2001-05-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Wakefield, 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.