Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FETAL SPIRAL ELECTRODE, MODEL FSE07000

K-Number: K030691 · 2003-09-17

ApplicantClinical Innovations, Inc.
Decision Date2003-09-17
Product CodeHGP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL SPIRAL ELECTRODE, MODEL FSE07000 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 2003-09-17 under 510(k) number K030691. 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 FETAL SPIRAL ELECTRODE, MODEL FSE07000?

FETAL SPIRAL ELECTRODE, MODEL FSE07000 is a medical device that received FDA 510(k) clearance on 2003-09-17. The listed applicant is Clinical Innovations, Inc.. The 510(k) number is K030691.

When did FETAL SPIRAL ELECTRODE, MODEL FSE07000 receive FDA 510(k) clearance?

FETAL SPIRAL ELECTRODE, MODEL FSE07000 received FDA 510(k) clearance on 2003-09-17, under 510(k) number K030691.

Who is the listed applicant for FETAL SPIRAL ELECTRODE, MODEL FSE07000?

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 FETAL SPIRAL ELECTRODE, MODEL FSE07000?

The FDA product code for FETAL SPIRAL ELECTRODE, MODEL FSE07000 is HGP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K022023COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500K003458SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000K981260KIWI 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

View all 9 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 ABK003458SOFT 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.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.

↑