minisono
K-Number: K182845 · 2018-12-27
ApplicantAlpinion Medical Systems Co., Ltd.
Decision Date2018-12-27
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
minisono is a medical device manufactured by Alpinion Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2018-12-27 under approval number K182845. 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 minisono?
minisono is a medical device that received FDA 510(k) clearance on 2018-12-27. It is manufactured by Alpinion Medical Systems Co., Ltd.. The 510(k) number is K182845.
When was minisono approved by the FDA?
minisono received FDA 510(k) clearance on 2018-12-27, under approval number K182845.
What company makes minisono?
minisono is manufactured by Alpinion Medical Systems Co., Ltd..
What is the FDA product code for minisono?
The FDA product code for minisono is IYN.
Other Devices by Alpinion Medical Systems Co., Ltd.
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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.