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FDA 510(k)

MODIFICATION TO FETAL ASSIST

K-Number: K020390 · 2002-04-19

ApplicantHuntleigh Diagnostics , Ltd.
Decision Date2002-04-19
Product CodeLQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO 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 2002-04-19 under 510(k) number K020390. The device is classified under product code LQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO FETAL ASSIST?

MODIFICATION TO FETAL ASSIST is a medical device that received FDA 510(k) clearance on 2002-04-19. The listed applicant is Huntleigh Diagnostics , Ltd.. The 510(k) number is K020390.

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

MODIFICATION TO FETAL ASSIST received FDA 510(k) clearance on 2002-04-19, under 510(k) number K020390.

Who is the listed applicant for MODIFICATION TO 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 MODIFICATION TO FETAL ASSIST?

The FDA product code for MODIFICATION TO FETAL ASSIST is LQK.

Related Clinical Trials

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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.

K002548FETAL ASSISTK001677BABY DOPPLEX 4000 (BD4000)

Related Devices (Code: LQK)

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.

K253673M•care System (MW-20)Marani Health, Inc.K221046Invu by NuvoNuvo- Group , Ltd.K210025INVU by NuvoNuvo- Group , Ltd.K191401PregSenseNuvo- Group , Ltd.

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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