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FDA 510(k)

TYSHAK NUCLEUS

K-Number: K121859 · 2012-08-31

ApplicantNuMED, Inc.
Decision Date2012-08-31
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TYSHAK NUCLEUS is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 2012-08-31 under 510(k) number K121859. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYSHAK NUCLEUS?

TYSHAK NUCLEUS is a medical device that received FDA 510(k) clearance on 2012-08-31. The listed applicant is NuMED, Inc.. The 510(k) number is K121859.

When did TYSHAK NUCLEUS receive FDA 510(k) clearance?

TYSHAK NUCLEUS received FDA 510(k) clearance on 2012-08-31, under 510(k) number K121859.

Who is the listed applicant for TYSHAK NUCLEUS?

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

What is the FDA product code for TYSHAK NUCLEUS?

The FDA product code for TYSHAK NUCLEUS is DQY.

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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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