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FDA 510(k)

GDXPRO

K-Number: K093521 · 2009-11-25

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2009-11-25
Product CodeMYC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GDXPRO is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2009-11-25 under 510(k) number K093521. The device is classified under product code MYC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GDXPRO?

GDXPRO is a medical device that received FDA 510(k) clearance on 2009-11-25. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K093521.

When did GDXPRO receive FDA 510(k) clearance?

GDXPRO received FDA 510(k) clearance on 2009-11-25, under 510(k) number K093521.

Who is the listed applicant for GDXPRO?

The FDA 510(k) record lists Carl Zeiss Meditec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GDXPRO?

The FDA product code for GDXPRO is MYC.

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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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