FDA 510(k)

PainFreeze II

K号: K232674 · 2024-02-12

决定日期2024-02-12

产品代码MLY

决定实质等同

器械摘要

PainFreeze II 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 2024-02-12 under 510(k) number K232674. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

常见问题

What is the PainFreeze II?

PainFreeze II is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Nuance Medical, LLC. The 510(k) number is K232674.

When did PainFreeze II receive FDA 510(k) clearance?

PainFreeze II received FDA 510(k) clearance on 2024-02-12, under 510(k) number K232674.

Who is the listed applicant for PainFreeze II?

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 PainFreeze II?

The FDA product code for PainFreeze II 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。

K210310CryoDose V 50/50，175ml 罐装套装，CryoDose V 50/50，236ml 罐装套装 K172203CryoDose TA OTC，雾喷，CryoDose TA OTC，流喷 K162218Pain Freeze®，中流量喷雾，型号#2101；Pain Freeze®，雾状喷雾，型号#2102。K161337CryoDose H 或类似

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