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FDA 510(k)

空氣流 PLUS 預防粉末

K 號：K171189 · 2017-09-11

申請人E.M.S Electro Medical Systems S.A
決定日期2017-09-11
產品代碼EJR
諮詢委員會DE
決定相當於

器材摘要

AIR-FLOW PLUS Prophylaxis powder 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 2017-09-11 under 510(k) number K171189. The device is classified under product code EJR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AIR-FLOW PLUS Prophylaxis powder?

AIR-FLOW PLUS Prophylaxis powder is a medical device that received FDA 510(k) clearance on 2017-09-11. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K171189.

When did AIR-FLOW PLUS Prophylaxis powder receive FDA 510(k) clearance?

AIR-FLOW PLUS Prophylaxis powder received FDA 510(k) clearance on 2017-09-11, under 510(k) number K171189.

Who is the listed applicant for AIR-FLOW PLUS Prophylaxis powder?

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 AIR-FLOW PLUS Prophylaxis powder?

The FDA product code for AIR-FLOW PLUS Prophylaxis powder is EJR.

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