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FDA 510(k)

BABY DOPPLEX (3000)

K-Number: K963711 · 1997-09-12

ApplicantHuntleigh Healthcare, Inc.
Decision Date1997-09-12
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BABY DOPPLEX (3000) is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare, Inc.. It received FDA 510(k) clearance on 1997-09-12 under 510(k) number K963711. 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 (3000)?

BABY DOPPLEX (3000) is a medical device that received FDA 510(k) clearance on 1997-09-12. The listed applicant is Huntleigh Healthcare, Inc.. The 510(k) number is K963711.

When did BABY DOPPLEX (3000) receive FDA 510(k) clearance?

BABY DOPPLEX (3000) received FDA 510(k) clearance on 1997-09-12, under 510(k) number K963711.

Who is the listed applicant for BABY DOPPLEX (3000)?

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

What is the FDA product code for BABY DOPPLEX (3000)?

The FDA product code for BABY DOPPLEX (3000) is HGM.

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Other records listing Huntleigh Healthcare, Inc. 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.

K032315IOP8 INTRA OPERATIVE PROBEK022786DVT60K010744FLOWTRON UNIVERSAL, MODEL AC600K012008STS RANGE , MODELS STS20,STS30,STS40K002186VASCULAR ASSISTK010894BABY DOPPLEX 3002 (BD3002)

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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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