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FDA 510(k)

COROMETRICS FETAL MOVEMENT DETECTION KIT

K-Number: K955559 · 1996-03-05

ApplicantGe Medical Systems Information Technologies
Decision Date1996-03-05
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COROMETRICS FETAL MOVEMENT DETECTION KIT 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 1996-03-05 under 510(k) number K955559. 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 FETAL MOVEMENT DETECTION KIT?

COROMETRICS FETAL MOVEMENT DETECTION KIT is a medical device that received FDA 510(k) clearance on 1996-03-05. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K955559.

When did COROMETRICS FETAL MOVEMENT DETECTION KIT receive FDA 510(k) clearance?

COROMETRICS FETAL MOVEMENT DETECTION KIT received FDA 510(k) clearance on 1996-03-05, under 510(k) number K955559.

Who is the listed applicant for COROMETRICS FETAL MOVEMENT DETECTION KIT?

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 FETAL MOVEMENT DETECTION KIT?

The FDA product code for COROMETRICS FETAL MOVEMENT DETECTION KIT is HGM.

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Other records listing Ge Medical Systems Information Technologies as applicant

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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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