FDA 510(k)

LIFEPAK® 35 AC电源适配器（41335-000001）

K号: K240162 · 2024-04-19

决定日期2024-04-19

产品代码MPD

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

LIFEPAK® 35 AC Power Adapter (41335-000001) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Physio-Control. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K240162. The device is classified under product code MPD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LIFEPAK® 35 AC Power Adapter (41335-000001)?

LIFEPAK® 35 AC Power Adapter (41335-000001) is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Stryker Physio-Control. The 510(k) number is K240162.

When did LIFEPAK® 35 AC Power Adapter (41335-000001) receive FDA 510(k) clearance?

LIFEPAK® 35 AC Power Adapter (41335-000001) received FDA 510(k) clearance on 2024-04-19, under 510(k) number K240162.

Who is the listed applicant for LIFEPAK® 35 AC Power Adapter (41335-000001)?

The FDA 510(k) record lists Stryker Physio-Control as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFEPAK® 35 AC Power Adapter (41335-000001)?

The FDA product code for LIFEPAK® 35 AC Power Adapter (41335-000001) is MPD.

列明Stryker Physio-Control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。

K240377LIFEPAK® ECG电缆

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。