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FDA 510(k)

DLX

K-Number: K945459 · 1995-01-30

ApplicantGeneral Electric Co.
Decision Date1995-01-30
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DLX is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1995-01-30 under 510(k) number K945459. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DLX?

DLX is a medical device that received FDA 510(k) clearance on 1995-01-30. The listed applicant is General Electric Co.. The 510(k) number is K945459.

When did DLX receive FDA 510(k) clearance?

DLX received FDA 510(k) clearance on 1995-01-30, under 510(k) number K945459.

Who is the listed applicant for DLX?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DLX?

The FDA product code for DLX is IZI.

Other records listing General Electric Co. as applicant

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Related Devices (Code: IZI)

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

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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