Baby Dopplex 4000, Model BD 4000
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K990569 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 4000, Model BD 4000, is a System, Monitoring, Perinatal device designed for fetal monitoring. It combines ultrasound and electrical signal processing to record fetal heart rate and uterine activity, providing continuous cardiotocographic (CTG) tracings for antepartum and intrapartum assessment. This device supports real-time fetal monitoring, enabling clinicians to evaluate fetal well-being and detect abnormalities during pregnancy and labor.
The Baby Dopplex 4000 is supplied as a reusable medical device intended for use in obstetric and gynecologic settings. It operates under FDA 510(k) clearance (K990569) and is classified as a Class II device under regulation 884.2740. The system requires proper calibration, maintenance, and storage in a clean, controlled environment to ensure accurate performance. No specific sterility requirements are noted, but adherence to standard infection control protocols is implied for reusable components.
Frequently asked questions
What is the Baby Dopplex 4000 BD 4000 used for?
The Baby Dopplex 4000 BD 4000 is a perinatal monitoring system designed specifically for fetal monitoring. It uses ultrasound and electrical signal processing to record fetal heart rate and uterine contractions, providing continuous cardiotocographic (CTG) tracings. These tracings help clinicians assess fetal well-being during both antepartum (before birth) and intrapartum (during labor) periods, enabling early detection of potential abnormalities.
Is the Baby Dopplex 4000 BD 4000 a single-use or reusable device?
The Baby Dopplex 4000 BD 4000 is a reusable medical device. While no specific sterility requirements are explicitly stated, it is intended for use in obstetric and gynecologic settings where standard infection control protocols must be followed for reusable components. Proper calibration, maintenance, and storage in a clean, controlled environment are essential to ensure accurate performance and safety.
What storage and maintenance requirements does the Baby Dopplex 4000 BD 4000 have?
The Baby Dopplex 4000 BD 4000 requires proper calibration and maintenance to function accurately. It should be stored in a clean, controlled environment to prevent contamination and ensure reliability. Since it is reusable, adherence to standard infection control protocols is implied for all reusable components. Regular servicing, as recommended by the manufacturer, will help maintain optimal performance and extend the device’s operational lifespan.
Does the Baby Dopplex 4000 BD 4000 come with multiple models or configurations?
The Baby Dopplex 4000 BD 4000 is a single model system, but it is registered under multiple FEI (Final Establishment Identification) numbers, which may correspond to different configurations, accessories, or software versions. These variations are typically managed through updates or optional add-ons provided by Huntleigh Healthcare. For specific configurations, refer to the manufacturer’s documentation or support resources.
What regulatory approvals does the Baby Dopplex 4000 BD 4000 hold?
The Baby Dopplex 4000 BD 4000 is cleared under the FDA’s 510(k) pathway with clearance number K990569. It is classified as a Class II device under regulation 884.2740 and is intended for use in obstetric and gynecologic settings. The device was reviewed by the Obstetrics/Gynecology Advisory Committee and is considered substantially equivalent to predicate devices.
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: PDF 614321-5 BD4000 USA User Manual - huntleigh-diagnostics.com, BABY DOPPLEX 4000, MODEL BD 4000 (K990569) — FDA 510 (k) | Innolitics, HUNTLEIGH BABY DOPPLEX 4000 USER MANUAL Pdf Download, HUNTLEIGH BABY DOPPLEX 4000 SERIES USER MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990569 | Class II | Active |
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Manufacturer
- Manufacturer
- Huntleigh Healthcare Limited
- FDA Applicant
- Huntleigh Healthcare, Inc.
Sources (1)
- FDA 510(k) K990569 24 fields · synced Oct 5, 2026