Avail
K-Number: K172079 · 2017-10-19
ApplicantOmron Healthcare, Inc.
Decision Date2017-10-19
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Avail is a medical device manufactured by Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2017-10-19 under approval number K172079. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Avail?
Avail is a medical device that received FDA 510(k) clearance on 2017-10-19. It is manufactured by Omron Healthcare, Inc.. The 510(k) number is K172079.
When was Avail approved by the FDA?
Avail received FDA 510(k) clearance on 2017-10-19, under approval number K172079.
What company makes Avail?
Avail is manufactured by Omron Healthcare, Inc..
What is the FDA product code for Avail?
The FDA product code for Avail is NUH.
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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.