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FDA 510(k)

MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM

K-Number: K882966 · 1988-10-05

ApplicantGe Medical Systems Information Technologies
Decision Date1988-10-05
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM 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 1988-10-05 under 510(k) number K882966. 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 320 FETAL/MATERNAL TELEMETRY SYSTEM?

MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 1988-10-05. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K882966.

When did MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM receive FDA 510(k) clearance?

MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM received FDA 510(k) clearance on 1988-10-05, under 510(k) number K882966.

Who is the listed applicant for MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM?

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 320 FETAL/MATERNAL TELEMETRY SYSTEM?

The FDA product code for MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM is HGM.

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Other records listing Ge Medical Systems Information Technologies as applicant

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K120770QT GUARD PLUS ANALYSIS SYSTEMK102426CARESCAPE MODEL V100 VITAL SIGNS MONITORK09236912SL ECG ANALYSIS PROGRAMK093141MARS HOLTER ANALYSIS WORKSTATIONK092027CARESCAPE MONITOR B850K090702MODIFICATION TO DASH 2500 PATIENT MONITOR

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Related Devices (Code: HGM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.

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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