FDA 510(k)

PAPAYA & PAPAYA Plus

K 號：K220423 · 2022-05-19

決定日期2022-05-19

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

PAPAYA & PAPAYA 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 2022-05-19 under 510(k) number K220423. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PAPAYA & PAPAYA Plus?

PAPAYA & PAPAYA Plus is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K220423.

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

PAPAYA & PAPAYA Plus received FDA 510(k) clearance on 2022-05-19, under 510(k) number K220423.

Who is the listed applicant for PAPAYA & PAPAYA 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 & PAPAYA Plus?

The FDA product code for PAPAYA & PAPAYA Plus is MUH.

其他以 Genoray Co., Ltd. 為申請人之記錄

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相關器械（代碼：MUH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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