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FDA 510(k)

SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000

K-Number: K003458 · 2001-05-03

ApplicantClinical Innovations, Inc.
Decision Date2001-05-03
Product CodeHGP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Innovations, Inc.. It received FDA 510(k) clearance on 2001-05-03 under 510(k) number K003458. 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 SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000?

SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 is a medical device that received FDA 510(k) clearance on 2001-05-03. The listed applicant is Clinical Innovations, Inc.. The 510(k) number is K003458.

When did SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 receive FDA 510(k) clearance?

SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 received FDA 510(k) clearance on 2001-05-03, under 510(k) number K003458.

Who is the listed applicant for SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000?

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

What is the FDA product code for SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000?

The FDA product code for SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 is HGP.

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Other records listing Clinical Innovations, 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.

K030691FETAL SPIRAL ELECTRODE, MODEL FSE07000K022023COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500K981260KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000MK974563COLPO CUP CVC-2000K974389KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETERK973746PRE-FILLED SYRINGE FOR KOALA IUP

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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.K943732LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCEGraphic Controls Corp.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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