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FDA 510(k)

FETAL ASSIST

K-Number: K002548 · 2001-03-06

ApplicantHuntleigh Diagnostics , Ltd.
Decision Date2001-03-06
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL ASSIST 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 2001-03-06 under 510(k) number K002548. 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 FETAL ASSIST?

FETAL ASSIST is a medical device that received FDA 510(k) clearance on 2001-03-06. The listed applicant is Huntleigh Diagnostics , Ltd.. The 510(k) number is K002548.

When did FETAL ASSIST receive FDA 510(k) clearance?

FETAL ASSIST received FDA 510(k) clearance on 2001-03-06, under 510(k) number K002548.

Who is the listed applicant for FETAL ASSIST?

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 FETAL ASSIST?

The FDA product code for FETAL ASSIST 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 ASSISTK001677BABY DOPPLEX 4000 (BD4000)

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

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

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