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 a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-07-21 under approval 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. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K170832.
When was Ultimax-i, DREX-UI80 V1.60 approved by the FDA?
Ultimax-i, DREX-UI80 V1.60 received FDA 510(k) clearance on 2017-07-21, under approval number K170832.
What company makes Ultimax-i, DREX-UI80 V1.60?
Ultimax-i, DREX-UI80 V1.60 is manufactured by Toshibamedical Systems Corporation.
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.