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FDA 510(k)

FETAL SCALP ELECTRODE

K-Number: K872057 · 1987-11-16

ApplicantMedical Accessories, Inc.
Decision Date1987-11-16
Product CodeHGP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL SCALP ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Accessories, Inc.. It received FDA 510(k) clearance on 1987-11-16 under 510(k) number K872057. 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 FETAL SCALP ELECTRODE?

FETAL SCALP ELECTRODE is a medical device that received FDA 510(k) clearance on 1987-11-16. The listed applicant is Medical Accessories, Inc.. The 510(k) number is K872057.

When did FETAL SCALP ELECTRODE receive FDA 510(k) clearance?

FETAL SCALP ELECTRODE received FDA 510(k) clearance on 1987-11-16, under 510(k) number K872057.

Who is the listed applicant for FETAL SCALP ELECTRODE?

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

What is the FDA product code for FETAL SCALP ELECTRODE?

The FDA product code for FETAL SCALP ELECTRODE 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 Medical Accessories, 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.

K920056POCKET SIZE FETAL HEART DETECTORK901152REDYPLATE DISPOSABLE LEG PLATE

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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