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FDA 510(k)

COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME

K-Number: K851252 · 1985-05-22

ApplicantGe Medical Systems Information Technologies
Decision Date1985-05-22
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME 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 1985-05-22 under 510(k) number K851252. 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 115 FETAL MONITOR W/DUAL CARDIOTACHOME?

COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME is a medical device that received FDA 510(k) clearance on 1985-05-22. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K851252.

When did COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME receive FDA 510(k) clearance?

COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME received FDA 510(k) clearance on 1985-05-22, under 510(k) number K851252.

Who is the listed applicant for COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME?

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 COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME?

The FDA product code for COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME is HGM.

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Related Devices (Code: HGM)

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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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