Baby Dopplex 3000 Mk 2 (BD3000)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K010889 FDA 510(k)
- FDA Product Code
- HGM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2740 FDA 510(k)
- Regulation Number
- 884.2740 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Baby Dopplex 3000 Mk 2 (BD3000) is a perinatal monitoring system used to show graphically the relationship between maternal labor and the fetal heart rate. It combines and coordinates uterine contraction and fetal heart monitors with appropriate displays of the data. The device is classified as a System, Monitoring, Perinatal device.
The Baby Dopplex 3000 Mk 2 (BD3000) is supplied with an FDA 510K authorization. The device is intended for use in obstetrics and gynecology settings, specifically for monitoring fetal heart rate during labor. It is a Class 2 device with the regulation number 884.2740.
Frequently asked questions
What is the Baby Dopplex 3000 Mk 2 used for?
The Baby Dopplex 3000 Mk 2 is a perinatal monitoring system used to graphically display the relationship between maternal labor and fetal heart rate, combining uterine contraction and fetal heart monitors with appropriate data displays.
How is the Baby Dopplex 3000 Mk 2 supplied?
The device is supplied with FDA 510K authorization and is intended for use in obstetrics and gynecology settings, specifically for monitoring fetal heart rate during labor.
What is the regulatory classification of the Baby Dopplex 3000 Mk 2?
The Baby Dopplex 3000 Mk 2 is classified as a Class 2 device with regulation number 884.2740 and is categorized as a System, Monitoring, Perinatal device.
What is the purpose of the advisory committee designation for this device?
The device was reviewed by the Obstetrics/Gynecology advisory committee, indicating it is specifically designed and intended for use in obstetric and gynecological settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Huntleigh Baby Dopplex 3000 Fetal Monitor - CardiacDirect, Baby Dopplex 3000 Fetal Monitor : Huntleigh BD3000 : Medical Equipment ..., BABY DOPPLEX 3000 MK 2 (BD3000) by HUNTLEIGH HEALTHCARE, INC. | FDA 510 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010889 | Class II | Active |
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Manufacturer
- Manufacturer
- Huntleigh Healthcare Limited
- FDA Applicant
- Huntleigh Healthcare, Inc.
Sources (1)
- FDA 510(k) K010889 24 fields · synced Oct 6, 2026