FDA 510(k)

GE 4096 PLUS & GE 2048

K-Number: K914267 · 1992-07-16

Decision Date1992-07-16

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GE 4096 PLUS & GE 2048 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1992-07-16 under 510(k) number K914267. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE 4096 PLUS & GE 2048?

GE 4096 PLUS & GE 2048 is a medical device that received FDA 510(k) clearance on 1992-07-16. The listed applicant is GE Medical Systems. The 510(k) number is K914267.

When did GE 4096 PLUS & GE 2048 receive FDA 510(k) clearance?

GE 4096 PLUS & GE 2048 received FDA 510(k) clearance on 1992-07-16, under 510(k) number K914267.

Who is the listed applicant for GE 4096 PLUS & GE 2048?

The FDA 510(k) record lists GE Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE 4096 PLUS & GE 2048?

The FDA product code for GE 4096 PLUS & GE 2048 is KPS.

Other records listing GE Medical Systems as applicant

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.