BABY DOPPLEX (3000)— 510(k) K963711

Substantially Equivalent

Huntleigh Healthcare, Inc.

FDA 510(k) clearance K963711 for BABY DOPPLEX (3000), Substantially Equivalent on 1997-09-12. Applicant: Huntleigh Healthcare, Inc..

Clearance details

Applicant: Huntleigh Healthcare, Inc.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 1996-09-16
Decision date: 1997-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manalapan, NJ, 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.