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FDA 510(k)

COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE

K-Number: K792669 · 1980-02-11

ApplicantGe Medical Systems Information Technologies
Decision Date1980-02-11
Product CodeHGP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 1980-02-11 under 510(k) number K792669. 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 COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE?

COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE is a medical device that received FDA 510(k) clearance on 1980-02-11. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K792669.

When did COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE receive FDA 510(k) clearance?

COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE received FDA 510(k) clearance on 1980-02-11, under 510(k) number K792669.

Who is the listed applicant for COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE?

The FDA 510(k) record lists Ge Medical Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE?

The FDA product code for COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE is HGP.

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Other records listing Ge Medical Systems Information Technologies 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.

K120770QT GUARD PLUS ANALYSIS SYSTEMK102426CARESCAPE MODEL V100 VITAL SIGNS MONITORK09236912SL ECG ANALYSIS PROGRAMK093141MARS HOLTER ANALYSIS WORKSTATIONK092027CARESCAPE MONITOR B850K090702MODIFICATION TO DASH 2500 PATIENT MONITOR

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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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