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FDA 510(k)

乙醚氯气中射流，乙醚氯气细点喷，乙醚氯气雾，乙醚氯气Accustream 360*中喷，乙醚氯气Accustream 360*细喷

K号: K190161 · 2019-05-07

申请人Gebauer Company
决定日期2019-05-07
产品代码MLY
决定实质等同

器械摘要

Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray is the device name listed in this FDA 510(k) record. The listed applicant is Gebauer Company. It received FDA 510(k) clearance on 2019-05-07 under 510(k) number K190161. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

常见问题

What is the Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray?

Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray is a medical device that received FDA 510(k) clearance on 2019-05-07. The listed applicant is Gebauer Company. The 510(k) number is K190161.

When did Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray receive FDA 510(k) clearance?

Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray received FDA 510(k) clearance on 2019-05-07, under 510(k) number K190161.

Who is the listed applicant for Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray?

FDA 510(k)记录显示Gebauer公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray?

The FDA product code for Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray is MLY.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Gebauer Company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。

K260870Gebauer的疼痛缓解局部麻醉皮肤制冷剂（雾状喷剂和中号喷剂）K172028Gebauer的疼痛缓解局部麻醉剂皮肤冷却剂（雾喷和中等喷雾）

相关器械（代码：MLY）

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。

K261684冻喷剂 TACryosurgery, Inc.K260870Gebauer的疼痛缓解局部麻醉皮肤制冷剂（雾状喷剂和中号喷剂）Gebauer CompanyK243654DentalJectVapocoolshot, Inc.K232674PainFreeze IINuance Medical, LLCK203661CRYO Arctic, CRYO PenguinCryoscience North America, Inc.K202782编号 Vapocoolant623 Medical, LLC

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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