FDA 510(k)

PAPAYA 3D 高級版 & PAPAYA 3D 高級版 Plus

K 號：K200469 · 2020-09-16

決定日期2020-09-16

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

PAPAYA 3D Premium & PAPAYA 3D Premium Plus 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 2020-09-16 under 510(k) number K200469. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PAPAYA 3D Premium & PAPAYA 3D Premium Plus?

PAPAYA 3D Premium & PAPAYA 3D Premium Plus is a medical device that received FDA 510(k) clearance on 2020-09-16. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K200469.

When did PAPAYA 3D Premium & PAPAYA 3D Premium Plus receive FDA 510(k) clearance?

PAPAYA 3D Premium & PAPAYA 3D Premium Plus received FDA 510(k) clearance on 2020-09-16, under 510(k) number K200469.

Who is the listed applicant for PAPAYA 3D Premium & PAPAYA 3D Premium Plus?

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 PAPAYA 3D Premium & PAPAYA 3D Premium Plus?

The FDA product code for PAPAYA 3D Premium & PAPAYA 3D Premium Plus is OAS.

其他以 Genoray Co., Ltd. 為申請人之記錄

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官方來源

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