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FDA 510(k)

OSCAR (OSCAR Prime, OSCAR Classic)

K-Number: K181943 · 2018-08-17

ApplicantGenoray Co., Ltd.
Decision Date2018-08-17
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OSCAR (OSCAR Prime, OSCAR Classic) 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 2018-08-17 under 510(k) number K181943. 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 (OSCAR Prime, OSCAR Classic)?

OSCAR (OSCAR Prime, OSCAR Classic) is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K181943.

When did OSCAR (OSCAR Prime, OSCAR Classic) receive FDA 510(k) clearance?

OSCAR (OSCAR Prime, OSCAR Classic) received FDA 510(k) clearance on 2018-08-17, under 510(k) number K181943.

Who is the listed applicant for OSCAR (OSCAR Prime, OSCAR Classic)?

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 (OSCAR Prime, OSCAR Classic)?

The FDA product code for OSCAR (OSCAR Prime, OSCAR Classic) is OWB.

Other records listing Genoray Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: OWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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