FDA 510(k)

DVAS (DVAS-M, DVAS-W)

K 號：K232085 · 2023-12-08

決定日期2023-12-08

產品代碼EHD

諮詢委員會DE

決定相當於

器材摘要

DVAS (DVAS-M, DVAS-W) 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 2023-12-08 under 510(k) number K232085. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DVAS (DVAS-M, DVAS-W)?

DVAS (DVAS-M, DVAS-W) is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K232085.

When did DVAS (DVAS-M, DVAS-W) receive FDA 510(k) clearance?

DVAS (DVAS-M, DVAS-W) received FDA 510(k) clearance on 2023-12-08, under 510(k) number K232085.

Who is the listed applicant for DVAS (DVAS-M, DVAS-W)?

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 DVAS (DVAS-M, DVAS-W)?

The FDA product code for DVAS (DVAS-M, DVAS-W) is EHD.

其他以 Genoray Co., Ltd. 為申請人之記錄

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相關器械（代碼：EHD）

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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