FDA 510(k)

设备名称：医疗设备监管文本设备名称：医疗设备监管文本公司/产品名称：保留 FDA：美国食品药品监督管理局 510(k)：510(k)通知 PMA：上市前批准 NCT：临床试验注册号 PMID：PubMed医学索引标识符：标识符 URL：网址政策：医疗监管v1 返回内容：保留原文

K号: K241963 · 2024-07-30

决定日期2024-07-30

产品代码EHD

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决定实质等同

器械摘要

WERAY is the device name listed in this FDA 510(k) record. The listed applicant is Picopack Co., Ltd.. It received FDA 510(k) clearance on 2024-07-30 under 510(k) number K241963. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the WERAY?

WERAY is a medical device that received FDA 510(k) clearance on 2024-07-30. The listed applicant is Picopack Co., Ltd.. The 510(k) number is K241963.

When did WERAY receive FDA 510(k) clearance?

WERAY received FDA 510(k) clearance on 2024-07-30, under 510(k) number K241963.

Who is the listed applicant for WERAY?

The FDA 510(k) record lists Picopack Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WERAY?

The FDA product code for WERAY is EHD.

官方来源

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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。

器械摘要

常见问题

相关临床试验

相关器械（代码：EHD）

官方来源