BABY DOPPLEX 3002 (BD3002)— 510(k) K010894

Name: FDA 510(k) clearance K010894
Creator: U.S. Food and Drug Administration
Published: 2001-04-25

Substantially Equivalent

Huntleigh Healthcare, Inc.

FDA 510(k) clearance K010894 for BABY DOPPLEX 3002 (BD3002), Substantially Equivalent on 2001-04-25. Applicant: Huntleigh Healthcare, Inc.. Device class: 2.

Clearance details

Applicant: Huntleigh Healthcare, Inc.
Product code: Code HGM
Device class: Class 2
Regulation: 21 CFR 884.2740
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 ↗

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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.