Oscar 15 & Oscar 15i
K-Number: K230787 · 2023-07-20
ApplicantGenoray Co., Ltd.
Decision Date2023-07-20
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Oscar 15 & Oscar 15i is a medical device manufactured by Genoray Co., Ltd.. It received FDA 510(k) clearance on 2023-07-20 under approval number K230787. 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 Oscar 15 & Oscar 15i?
Oscar 15 & Oscar 15i is a medical device that received FDA 510(k) clearance on 2023-07-20. It is manufactured by Genoray Co., Ltd.. The 510(k) number is K230787.
When was Oscar 15 & Oscar 15i approved by the FDA?
Oscar 15 & Oscar 15i received FDA 510(k) clearance on 2023-07-20, under approval number K230787.
What company makes Oscar 15 & Oscar 15i?
Oscar 15 & Oscar 15i is manufactured by Genoray Co., Ltd..
What is the FDA product code for Oscar 15 & Oscar 15i?
The FDA product code for Oscar 15 & Oscar 15i 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.