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FDA 510(k)

FETAL MONITOR MODEL 112

K-Number: K780177 · 1978-03-02

ApplicantGe Medical Systems Information Technologies
Decision Date1978-03-02
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FETAL MONITOR MODEL 112 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 1978-03-02 under 510(k) number K780177. 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 FETAL MONITOR MODEL 112?

FETAL MONITOR MODEL 112 is a medical device that received FDA 510(k) clearance on 1978-03-02. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K780177.

When did FETAL MONITOR MODEL 112 receive FDA 510(k) clearance?

FETAL MONITOR MODEL 112 received FDA 510(k) clearance on 1978-03-02, under 510(k) number K780177.

Who is the listed applicant for FETAL MONITOR MODEL 112?

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

What is the FDA product code for FETAL MONITOR MODEL 112?

The FDA product code for FETAL MONITOR MODEL 112 is HGM.

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Other records listing Ge Medical Systems Information Technologies as applicant

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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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