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FDA 510(k)

TYSHAK, MODEL 102 AND Z-MED, MODEL 302

K-Number: K991977 · 2000-09-27

ApplicantNuMED, Inc.
Decision Date2000-09-27
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TYSHAK, MODEL 102 AND Z-MED, MODEL 302 is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 2000-09-27 under 510(k) number K991977. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYSHAK, MODEL 102 AND Z-MED, MODEL 302?

TYSHAK, MODEL 102 AND Z-MED, MODEL 302 is a medical device that received FDA 510(k) clearance on 2000-09-27. The listed applicant is NuMED, Inc.. The 510(k) number is K991977.

When did TYSHAK, MODEL 102 AND Z-MED, MODEL 302 receive FDA 510(k) clearance?

TYSHAK, MODEL 102 AND Z-MED, MODEL 302 received FDA 510(k) clearance on 2000-09-27, under 510(k) number K991977.

Who is the listed applicant for TYSHAK, MODEL 102 AND Z-MED, MODEL 302?

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, MODEL 102 AND Z-MED, MODEL 302?

The FDA product code for TYSHAK, MODEL 102 AND Z-MED, MODEL 302 is LIT.

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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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