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FDA 510(k)

Z-MED Z-MED II

K-Number: K122012 · 2012-10-04

ApplicantNuMED, Inc.
Decision Date2012-10-04
Product CodeOZT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Z-MED Z-MED II is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 2012-10-04 under 510(k) number K122012. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z-MED Z-MED II?

Z-MED Z-MED II is a medical device that received FDA 510(k) clearance on 2012-10-04. The listed applicant is NuMED, Inc.. The 510(k) number is K122012.

When did Z-MED Z-MED II receive FDA 510(k) clearance?

Z-MED Z-MED II received FDA 510(k) clearance on 2012-10-04, under 510(k) number K122012.

Who is the listed applicant for Z-MED Z-MED II?

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 Z-MED Z-MED II?

The FDA product code for Z-MED Z-MED II is OZT.

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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.

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