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FDA 510(k)

COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST

K-Number: K910260 · 1991-03-15

ApplicantGe Medical Systems Information Technologies
Decision Date1991-03-15
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST 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 1991-03-15 under 510(k) number K910260. 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 MDL 330 FETAL/MATERNAL TELEMETRY SYST?

COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST is a medical device that received FDA 510(k) clearance on 1991-03-15. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K910260.

When did COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST receive FDA 510(k) clearance?

COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST received FDA 510(k) clearance on 1991-03-15, under 510(k) number K910260.

Who is the listed applicant for COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST?

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 MDL 330 FETAL/MATERNAL TELEMETRY SYST?

The FDA product code for COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST 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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