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FDA 510(k)

FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM

K-Number: K801984 · 1980-09-09

ApplicantLife Support, Inc.
Decision Date1980-09-09
Product CodeHGP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Life Support, Inc.. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801984. The device is classified under product code HGP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM?

FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Life Support, Inc.. The 510(k) number is K801984.

When did FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM receive FDA 510(k) clearance?

FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801984.

Who is the listed applicant for FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM?

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

What is the FDA product code for FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM?

The FDA product code for FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM is HGP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Life Support, 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.

K791633UC-2000 UTERINE CATHERIZATION SYSTEM

Related Devices (Code: HGP)

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.

K243291Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)Neoventa Medical ABK030691FETAL SPIRAL ELECTRODE, MODEL FSE07000Clinical Innovations, Inc.K003458SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000Clinical Innovations, Inc.K943732LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCEGraphic Controls Corp.K910815CR SPIRAL ELECTRODENeward Enterprises, Inc.K911657FETAL SCALP SPIRAL ELECTRODEAdvanced Medical Systems, 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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