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FDA 510(k)

CR SPIRAL ELECTRODE

K-Number: K910815 · 1991-12-10

ApplicantNeward Enterprises, Inc.
Decision Date1991-12-10
Product CodeHGP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CR SPIRAL ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Neward Enterprises, Inc.. It received FDA 510(k) clearance on 1991-12-10 under 510(k) number K910815. 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 CR SPIRAL ELECTRODE?

CR SPIRAL ELECTRODE is a medical device that received FDA 510(k) clearance on 1991-12-10. The listed applicant is Neward Enterprises, Inc.. The 510(k) number is K910815.

When did CR SPIRAL ELECTRODE receive FDA 510(k) clearance?

CR SPIRAL ELECTRODE received FDA 510(k) clearance on 1991-12-10, under 510(k) number K910815.

Who is the listed applicant for CR SPIRAL ELECTRODE?

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

What is the FDA product code for CR SPIRAL ELECTRODE?

The FDA product code for CR SPIRAL ELECTRODE is HGP.

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Other records listing Neward Enterprises, 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.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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