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FDA 510(k)

MODEL 250 SERIES MATERNAL/FETAL MONITOR

K-Number: K050583 · 2005-06-21

ApplicantGe Medical Systems Information Technologies
Decision Date2005-06-21
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL 250 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 2005-06-21 under 510(k) number K050583. 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 250 SERIES MATERNAL/FETAL MONITOR?

MODEL 250 SERIES MATERNAL/FETAL MONITOR is a medical device that received FDA 510(k) clearance on 2005-06-21. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K050583.

When did MODEL 250 SERIES MATERNAL/FETAL MONITOR receive FDA 510(k) clearance?

MODEL 250 SERIES MATERNAL/FETAL MONITOR received FDA 510(k) clearance on 2005-06-21, under 510(k) number K050583.

Who is the listed applicant for MODEL 250 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 250 SERIES MATERNAL/FETAL MONITOR?

The FDA product code for MODEL 250 SERIES MATERNAL/FETAL MONITOR 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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