FDA 510(k)

DolorClast 體外震波治療器

K 號：K220538 · 2022-07-11

決定日期2022-07-11

產品代碼ISA

諮詢委員會PM

決定相當於

器材摘要

DolorClast Radial is the device name listed in this FDA 510(k) record. The listed applicant is E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2022-07-11 under 510(k) number K220538. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DolorClast Radial?

DolorClast Radial is a medical device that received FDA 510(k) clearance on 2022-07-11. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K220538.

When did DolorClast Radial receive FDA 510(k) clearance?

DolorClast Radial received FDA 510(k) clearance on 2022-07-11, under 510(k) number K220538.

Who is the listed applicant for DolorClast Radial?

The FDA 510(k) record lists E.M.S Electro Medical Systems S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DolorClast Radial?

The FDA product code for DolorClast Radial is ISA.

其他以 E.M.S Electro Medical Systems S.A 為申請人之記錄

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