FDA 510(k)

DEEP GRAY

K-Number: K012563 · 2001-11-02

Decision Date2001-11-02

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DEEP GRAY is the device name listed in this FDA 510(k) record. The listed applicant is Cortechs Labs, Inc.. It received FDA 510(k) clearance on 2001-11-02 under 510(k) number K012563. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEEP GRAY?

DEEP GRAY is a medical device that received FDA 510(k) clearance on 2001-11-02. The listed applicant is Cortechs Labs, Inc.. The 510(k) number is K012563.

When did DEEP GRAY receive FDA 510(k) clearance?

DEEP GRAY received FDA 510(k) clearance on 2001-11-02, under 510(k) number K012563.

Who is the listed applicant for DEEP GRAY?

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

What is the FDA product code for DEEP GRAY?

The FDA product code for DEEP GRAY is LLZ.

Other records listing Cortechs Labs, Inc. as applicant

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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.