FDA 510(k)

CryoDose TA OTC，雾喷，CryoDose TA OTC，流喷

K号: K172203 · 2017-10-18

决定日期2017-10-18

产品代码MLY

决定实质等同

器械摘要

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray is the device name listed in this FDA 510(k) record. The listed applicant is Nuance Medical, LLC. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K172203. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

常见问题

What is the CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray?

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Nuance Medical, LLC. The 510(k) number is K172203.

When did CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray receive FDA 510(k) clearance?

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray received FDA 510(k) clearance on 2017-10-18, under 510(k) number K172203.

Who is the listed applicant for CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray?

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

What is the FDA product code for CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray?

The FDA product code for CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray is MLY.

列明Nuance Medical, LLC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。

K232674PainFreeze II K210310CryoDose V 50/50，175ml 罐装套装，CryoDose V 50/50，236ml 罐装套装 K162218Pain Freeze®，中流量喷雾，型号#2101；Pain Freeze®，雾状喷雾，型号#2102。K161337CryoDose H 或类似

官方来源

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