FDA 510(k)

D²RS 及 D²RS 9090

K 號：K221335 · 2022-06-07

決定日期2022-06-07

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

D²RS and D²RS 9090 is the device name listed in this FDA 510(k) record. The listed applicant is Stephanix. It received FDA 510(k) clearance on 2022-06-07 under 510(k) number K221335. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the D²RS and D²RS 9090?

D²RS and D²RS 9090 is a medical device that received FDA 510(k) clearance on 2022-06-07. The listed applicant is Stephanix. The 510(k) number is K221335.

When did D²RS and D²RS 9090 receive FDA 510(k) clearance?

D²RS and D²RS 9090 received FDA 510(k) clearance on 2022-06-07, under 510(k) number K221335.

Who is the listed applicant for D²RS and D²RS 9090?

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

What is the FDA product code for D²RS and D²RS 9090?

The FDA product code for D²RS and D²RS 9090 is OWB.

其他以 Stephanix 為申請人之記錄

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。

K213479D²RS 及 D²RS 9090 K212515MOVIX DReamy

相關器械（代碼：OWB）

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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官方來源

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