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FDA 510(k)

GDX VCC WITH ECC SOFTWARE

K-Number: K082016 · 2009-08-10

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2009-08-10
Product CodeMYC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GDX VCC WITH ECC SOFTWARE 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 2009-08-10 under 510(k) number K082016. 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 GDX VCC WITH ECC SOFTWARE?

GDX VCC WITH ECC SOFTWARE is a medical device that received FDA 510(k) clearance on 2009-08-10. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K082016.

When did GDX VCC WITH ECC SOFTWARE receive FDA 510(k) clearance?

GDX VCC WITH ECC SOFTWARE received FDA 510(k) clearance on 2009-08-10, under 510(k) number K082016.

Who is the listed applicant for GDX VCC WITH ECC SOFTWARE?

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 GDX VCC WITH ECC SOFTWARE?

The FDA product code for GDX VCC WITH ECC SOFTWARE 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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