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FDA 510(k)

TI-MAX Z45

K-Number: K121901 · 2013-02-28

ApplicantNakanishi, Inc.
Decision Date2013-02-28
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TI-MAX Z45 is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2013-02-28 under 510(k) number K121901. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TI-MAX Z45?

TI-MAX Z45 is a medical device that received FDA 510(k) clearance on 2013-02-28. The listed applicant is Nakanishi, Inc.. The 510(k) number is K121901.

When did TI-MAX Z45 receive FDA 510(k) clearance?

TI-MAX Z45 received FDA 510(k) clearance on 2013-02-28, under 510(k) number K121901.

Who is the listed applicant for TI-MAX Z45?

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

What is the FDA product code for TI-MAX Z45?

The FDA product code for TI-MAX Z45 is EGS.

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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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