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FDA 510(k)

LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE

K-Number: K943732 · 1994-10-20

ApplicantGraphic Controls Corp.
Decision Date1994-10-20
Product CodeHGP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE 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 1994-10-20 under 510(k) number K943732. 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 LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE?

LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE is a medical device that received FDA 510(k) clearance on 1994-10-20. The listed applicant is Graphic Controls Corp.. The 510(k) number is K943732.

When did LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE receive FDA 510(k) clearance?

LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE received FDA 510(k) clearance on 1994-10-20, under 510(k) number K943732.

Who is the listed applicant for LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE?

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 LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE?

The FDA product code for LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE 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

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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.K910815CR SPIRAL ELECTRODENeward Enterprises, Inc.K911657FETAL SCALP SPIRAL ELECTRODEAdvanced Medical Systems, Inc.K905830COMBO FETAL SCALP ELECTRODE/LEGPLATEUtah Medical Products, 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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