AIR-FLOW PLUS 预防粉末
K号: K171189 · 2017-09-11
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决定日期2017-09-11
产品代码EJR
咨询委员会DE
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
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列明E.M.S Electro Medical Systems S.A为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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