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FDA 510(k)

COROMETRICS 815 FETAL ECG RECORDER

K-Number: K841477 · 1984-05-14

ApplicantGe Medical Systems Information Technologies
Decision Date1984-05-14
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COROMETRICS 815 FETAL ECG RECORDER 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 1984-05-14 under 510(k) number K841477. 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 815 FETAL ECG RECORDER?

COROMETRICS 815 FETAL ECG RECORDER is a medical device that received FDA 510(k) clearance on 1984-05-14. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K841477.

When did COROMETRICS 815 FETAL ECG RECORDER receive FDA 510(k) clearance?

COROMETRICS 815 FETAL ECG RECORDER received FDA 510(k) clearance on 1984-05-14, under 510(k) number K841477.

Who is the listed applicant for COROMETRICS 815 FETAL ECG RECORDER?

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 815 FETAL ECG RECORDER?

The FDA product code for COROMETRICS 815 FETAL ECG RECORDER 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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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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