FDA 510(k)

DABRA 激光系統（DABRA 激光型號 RA-308 及 DABRA 穿刺管型號 2.0）

K 號：K220544 · 2022-06-29

決定日期2022-06-29

產品代碼PDU

諮詢委員會履歷

決定相當於

器材摘要

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) is the device name listed in this FDA 510(k) record. The listed applicant is Ra Medical Systems,Inc. It received FDA 510(k) clearance on 2022-06-29 under 510(k) number K220544. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)?

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) is a medical device that received FDA 510(k) clearance on 2022-06-29. The listed applicant is Ra Medical Systems,Inc. The 510(k) number is K220544.

When did DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) receive FDA 510(k) clearance?

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) received FDA 510(k) clearance on 2022-06-29, under 510(k) number K220544.

Who is the listed applicant for DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)?

The FDA 510(k) record lists Ra Medical Systems,Inc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)?

The FDA product code for DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) is PDU.

其他以 Ra Medical Systems,Inc 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。

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相關器械（代碼：PDU）

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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