HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS
K-Number: K153421 · 2016-01-21
ApplicantHitachi Aloka Medical America, Inc.
Decision Date2016-01-21
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS is a medical device manufactured by Hitachi Aloka Medical America, Inc.. It received FDA 510(k) clearance on 2016-01-21 under approval number K153421. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS?
HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS is a medical device that received FDA 510(k) clearance on 2016-01-21. It is manufactured by Hitachi Aloka Medical America, Inc.. The 510(k) number is K153421.
When was HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS approved by the FDA?
HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS received FDA 510(k) clearance on 2016-01-21, under approval number K153421.
What company makes HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS?
HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS is manufactured by Hitachi Aloka Medical America, Inc..
What is the FDA product code for HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS?
The FDA product code for HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS is IYN.
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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.