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)

FETASONDE UTERINE WORK MONITOR

K-Number: K791036 · 1979-09-04

ApplicantRoche Medical Electronics, Inc.
Decision Date1979-09-04
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETASONDE UTERINE WORK MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Roche Medical Electronics, Inc.. It received FDA 510(k) clearance on 1979-09-04 under 510(k) number K791036. 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 FETASONDE UTERINE WORK MONITOR?

FETASONDE UTERINE WORK MONITOR is a medical device that received FDA 510(k) clearance on 1979-09-04. The listed applicant is Roche Medical Electronics, Inc.. The 510(k) number is K791036.

When did FETASONDE UTERINE WORK MONITOR receive FDA 510(k) clearance?

FETASONDE UTERINE WORK MONITOR received FDA 510(k) clearance on 1979-09-04, under 510(k) number K791036.

Who is the listed applicant for FETASONDE UTERINE WORK MONITOR?

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

What is the FDA product code for FETASONDE UTERINE WORK MONITOR?

The FDA product code for FETASONDE UTERINE WORK 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 Roche Medical Electronics, 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.

K791559ROCHE SENSOR ADAPTORK791038FETASONDE UTERINE ACTIVITY MONITORK791037FETASONDE LABOR STATUS DISPLAYK791039FETASONDE FETAL HEART RATE VARIABILITYK791035FETASONDE FETAL ACTIVITY MONITORK790761FETASONDE MODEL 2108

View all 16 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.

↑