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FDA 510(k)

DISPLAY SYSTEM MODEL 428

K-Number: K780176 · 1978-03-02

ApplicantGe Medical Systems Information Technologies
Decision Date1978-03-02
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DISPLAY SYSTEM MODEL 428 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 1978-03-02 under 510(k) number K780176. 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 DISPLAY SYSTEM MODEL 428?

DISPLAY SYSTEM MODEL 428 is a medical device that received FDA 510(k) clearance on 1978-03-02. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K780176.

When did DISPLAY SYSTEM MODEL 428 receive FDA 510(k) clearance?

DISPLAY SYSTEM MODEL 428 received FDA 510(k) clearance on 1978-03-02, under 510(k) number K780176.

Who is the listed applicant for DISPLAY SYSTEM MODEL 428?

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 DISPLAY SYSTEM MODEL 428?

The FDA product code for DISPLAY SYSTEM MODEL 428 is 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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