Demi Ultra
K-Number: K163064 · 2017-07-18
ApplicantKerr Corporation
Decision Date2017-07-18
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Demi Ultra is a medical device manufactured by Kerr Corporation. It received FDA 510(k) clearance on 2017-07-18 under approval number K163064. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Demi Ultra?
Demi Ultra is a medical device that received FDA 510(k) clearance on 2017-07-18. It is manufactured by Kerr Corporation. The 510(k) number is K163064.
When was Demi Ultra approved by the FDA?
Demi Ultra received FDA 510(k) clearance on 2017-07-18, under approval number K163064.
What company makes Demi Ultra?
Demi Ultra is manufactured by Kerr Corporation.
What is the FDA product code for Demi Ultra?
The FDA product code for Demi Ultra is EBZ.
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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.