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FDA 510(k)

FETASONDE FETAL ACTIVITY MONITOR

K-Number: K791035 · 1979-09-04

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

Device Summary

FETASONDE FETAL ACTIVITY 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 K791035. 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 FETAL ACTIVITY MONITOR?

FETASONDE FETAL ACTIVITY 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 K791035.

When did FETASONDE FETAL ACTIVITY MONITOR receive FDA 510(k) clearance?

FETASONDE FETAL ACTIVITY MONITOR received FDA 510(k) clearance on 1979-09-04, under 510(k) number K791035.

Who is the listed applicant for FETASONDE FETAL ACTIVITY 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 FETAL ACTIVITY MONITOR?

The FDA product code for FETASONDE FETAL ACTIVITY MONITOR is HGM.

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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 ADAPTORK791037FETASONDE LABOR STATUS DISPLAYK791036FETASONDE UTERINE WORK MONITORK791039FETASONDE FETAL HEART RATE VARIABILITYK791038FETASONDE UTERINE ACTIVITY MONITORK790761FETASONDE MODEL 2108

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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.

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