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FDA 510(k)

MODEL 120 SERIES MATERNAL/FETAL MONITOR

K-Number: K032252 · 2003-08-21

ApplicantGe Medical Systems Information Technologies
Decision Date2003-08-21
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL 120 SERIES MATERNAL/FETAL MONITOR 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 2003-08-21 under 510(k) number K032252. 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 MODEL 120 SERIES MATERNAL/FETAL MONITOR?

MODEL 120 SERIES MATERNAL/FETAL MONITOR is a medical device that received FDA 510(k) clearance on 2003-08-21. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K032252.

When did MODEL 120 SERIES MATERNAL/FETAL MONITOR receive FDA 510(k) clearance?

MODEL 120 SERIES MATERNAL/FETAL MONITOR received FDA 510(k) clearance on 2003-08-21, under 510(k) number K032252.

Who is the listed applicant for MODEL 120 SERIES MATERNAL/FETAL MONITOR?

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 MODEL 120 SERIES MATERNAL/FETAL MONITOR?

The FDA product code for MODEL 120 SERIES MATERNAL/FETAL MONITOR 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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