FDA 510(k)

用于LIFEPAK除颤器/监护仪的灭菌内部除颤电极

K号: K182503 · 2019-06-03

决定日期2019-06-03

产品代码LDD

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

Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control, Inc.. It received FDA 510(k) clearance on 2019-06-03 under 510(k) number K182503. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors?

Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors is a medical device that received FDA 510(k) clearance on 2019-06-03. The listed applicant is Physio-Control, Inc.. The 510(k) number is K182503.

When did Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors receive FDA 510(k) clearance?

Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors received FDA 510(k) clearance on 2019-06-03, under 510(k) number K182503.

Who is the listed applicant for Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors?

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

What is the FDA product code for Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors?

The FDA product code for Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors is LDD.

列明Physio-Control, Inc.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。

K253099LIFEPAK 15 AC电源适配器（41577-000333）K240156LIFEPAK® 侵入性压力适配器电缆（与ICU Medical Transpack IV侵入性压力传感器（或等效）接口）（11230-000021）；LIFEPAK® 侵入性压力适配器电缆（与Edwards Lifesciences TruWave侵入性压力传感器（或等效）接口）（11230-000024）

官方来源

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