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FDA 510(k)

MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE

K-Number: K904745 · 1991-01-29

ApplicantGraphic Controls Corp.
Decision Date1991-01-29
Product CodeHGP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Graphic Controls Corp.. It received FDA 510(k) clearance on 1991-01-29 under 510(k) number K904745. 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 MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE?

MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE is a medical device that received FDA 510(k) clearance on 1991-01-29. The listed applicant is Graphic Controls Corp.. The 510(k) number is K904745.

When did MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE receive FDA 510(k) clearance?

MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE received FDA 510(k) clearance on 1991-01-29, under 510(k) number K904745.

Who is the listed applicant for MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE?

The FDA 510(k) record lists Graphic Controls Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE?

The FDA product code for MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE is HGP.

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Other records listing Graphic Controls Corp. 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.

K981964MEDI-TRACE 4103 NEONATAL ELECTRODEK983287MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEK972970MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK964387POINT OF USE II SHARPS-A-GATOR

View all 55 devices →

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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