FDA 510(k)

Pixie Pulse (SM9068)

K号: K241365 · 2024-08-12

决定日期2024-08-12

产品代码NUH

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器械摘要

Pixie Pulse (SM9068) is the device name listed in this FDA 510(k) record. The listed applicant is Pixie Cup, LLC. It received FDA 510(k) clearance on 2024-08-12 under 510(k) number K241365. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pixie Pulse (SM9068)?

Pixie Pulse (SM9068) is a medical device that received FDA 510(k) clearance on 2024-08-12. The listed applicant is Pixie Cup, LLC. The 510(k) number is K241365.

When did Pixie Pulse (SM9068) receive FDA 510(k) clearance?

Pixie Pulse (SM9068) received FDA 510(k) clearance on 2024-08-12, under 510(k) number K241365.

Who is the listed applicant for Pixie Pulse (SM9068)?

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

What is the FDA product code for Pixie Pulse (SM9068)?

The FDA product code for Pixie Pulse (SM9068) is NUH.

相关器械（代码：NUH）

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。

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器械摘要

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相关器械（代码：NUH）

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