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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2023-07-20 under 510(k) 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. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K230787.

When did Oscar 15 & Oscar 15i receive FDA 510(k) clearance?

Oscar 15 & Oscar 15i received FDA 510(k) clearance on 2023-07-20, under 510(k) number K230787.

Who is the listed applicant for Oscar 15 & Oscar 15i?

The FDA 510(k) record lists Genoray Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oscar 15 & Oscar 15i?

The FDA product code for Oscar 15 & Oscar 15i is OWB.

Other records listing Genoray Co., Ltd. as applicant

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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.

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