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)

COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR

K-Number: K991739 · 1999-08-19

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date1999-08-19
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Medical Systems Information Techn. It received FDA 510(k) clearance on 1999-08-19 under 510(k) number K991739. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR?

COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR is a medical device that received FDA 510(k) clearance on 1999-08-19. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K991739.

When did COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR receive FDA 510(k) clearance?

COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR received FDA 510(k) clearance on 1999-08-19, under 510(k) number K991739.

Who is the listed applicant for COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR?

The FDA 510(k) record lists General Electric Medical Systems Information Techn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR?

The FDA product code for COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR is HGM.

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 General Electric Medical Systems Information Techn 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.

K023380T-WAVE ALTERMANS (TWA) ALGORITHM OPTIONK021470SEER LIGHT COMPACT DIGITAL HOLTER RECORDERK023100ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTSK021454UNITY NETWORK IDK020290DASH 3000/4000 PATIENT MONITORK021366MAC-LAB/CARDIOLAB EP/COMBOLAB

View all 33 devices →

Related Devices (Code: HGM)

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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, 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.

↑