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FDA 510(k)

MULTI-PRONG FETAL SCALP ELECTRODE

K-Number: K822584 · 1983-02-24

ApplicantKontron Instruments, Inc.
Decision Date1983-02-24
Product CodeHGP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MULTI-PRONG FETAL SCALP ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Kontron Instruments, Inc.. It received FDA 510(k) clearance on 1983-02-24 under 510(k) number K822584. 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 MULTI-PRONG FETAL SCALP ELECTRODE?

MULTI-PRONG FETAL SCALP ELECTRODE is a medical device that received FDA 510(k) clearance on 1983-02-24. The listed applicant is Kontron Instruments, Inc.. The 510(k) number is K822584.

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

MULTI-PRONG FETAL SCALP ELECTRODE received FDA 510(k) clearance on 1983-02-24, under 510(k) number K822584.

Who is the listed applicant for MULTI-PRONG FETAL SCALP ELECTRODE?

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

What is the FDA product code for MULTI-PRONG FETAL SCALP ELECTRODE?

The FDA product code for MULTI-PRONG FETAL SCALP ELECTRODE is HGP.

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Other records listing Kontron Instruments, 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.

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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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