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FDA 510(k)

GRANDTEC

K-Number: K102347 · 2010-10-29

ApplicantVoco GmbH
Decision Date2010-10-29
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GRANDTEC is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2010-10-29 under 510(k) number K102347. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRANDTEC?

GRANDTEC is a medical device that received FDA 510(k) clearance on 2010-10-29. The listed applicant is Voco GmbH. The 510(k) number is K102347.

When did GRANDTEC receive FDA 510(k) clearance?

GRANDTEC received FDA 510(k) clearance on 2010-10-29, under 510(k) number K102347.

Who is the listed applicant for GRANDTEC?

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

What is the FDA product code for GRANDTEC?

The FDA product code for GRANDTEC is EBI.

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Related Devices (Code: EBI)

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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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