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FDA 510(k)

BABY DOPPLEX 4000 (BD4000)

K-Number: K001677 · 2000-08-14

ApplicantHuntleigh Diagnostics , Ltd.
Decision Date2000-08-14
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BABY DOPPLEX 4000 (BD4000) is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Diagnostics , Ltd.. It received FDA 510(k) clearance on 2000-08-14 under 510(k) number K001677. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BABY DOPPLEX 4000 (BD4000)?

BABY DOPPLEX 4000 (BD4000) is a medical device that received FDA 510(k) clearance on 2000-08-14. The listed applicant is Huntleigh Diagnostics , Ltd.. The 510(k) number is K001677.

When did BABY DOPPLEX 4000 (BD4000) receive FDA 510(k) clearance?

BABY DOPPLEX 4000 (BD4000) received FDA 510(k) clearance on 2000-08-14, under 510(k) number K001677.

Who is the listed applicant for BABY DOPPLEX 4000 (BD4000)?

The FDA 510(k) record lists Huntleigh Diagnostics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BABY DOPPLEX 4000 (BD4000)?

The FDA product code for BABY DOPPLEX 4000 (BD4000) is HGM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Huntleigh Diagnostics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K020390MODIFICATION TO FETAL ASSISTK002548FETAL ASSIST

Related Devices (Code: HGM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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