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FDA 510(k)

Ultimax-i, DREX-UI80 V1.60

K-Number: K170832 · 2017-07-21

ApplicantToshibamedical Systems Corporation
Decision Date2017-07-21
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ultimax-i, DREX-UI80 V1.60 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K170832. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultimax-i, DREX-UI80 V1.60?

Ultimax-i, DREX-UI80 V1.60 is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K170832.

When did Ultimax-i, DREX-UI80 V1.60 receive FDA 510(k) clearance?

Ultimax-i, DREX-UI80 V1.60 received FDA 510(k) clearance on 2017-07-21, under 510(k) number K170832.

Who is the listed applicant for Ultimax-i, DREX-UI80 V1.60?

The FDA 510(k) record lists Toshibamedical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultimax-i, DREX-UI80 V1.60?

The FDA product code for Ultimax-i, DREX-UI80 V1.60 is OWB.

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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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