FDA 510(k)

PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG

K 號：K221144 · 2022-05-13

決定日期2022-05-13

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG is the device name listed in this FDA 510(k) record. The listed applicant is Radisen Co., Ltd.. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K221144. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG?

PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Radisen Co., Ltd.. The 510(k) number is K221144.

When did PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG receive FDA 510(k) clearance?

PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG received FDA 510(k) clearance on 2022-05-13, under 510(k) number K221144.

Who is the listed applicant for PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG?

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

What is the FDA product code for PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG?

The FDA product code for PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG is MQB.

其他以 Radisen Co., Ltd. 為申請人之記錄

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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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