BABY DOPPLEX 3000 MK 2 (BD3000)— 510(k) K010889

Substantially Equivalent

Huntleigh Healthcare, Inc.

FDA 510(k) clearance K010889 for BABY DOPPLEX 3000 MK 2 (BD3000), Substantially Equivalent on 2001-04-25. Applicant: Huntleigh Healthcare, Inc..

Clearance details

Applicant: Huntleigh Healthcare, Inc.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2001-03-26
Decision date: 2001-04-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Cardiff, GB

Download summary PDF View on FDA.gov ↗

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.