自动体外除颤器（非穿戴）
PMA编号：P170018 · 2026-07-30
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决定日期2026-07-30
PMA 编号P170018
产品代码MKJ
设备分类第3类
医疗专科C
法规编号21 CFR 8
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：
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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]
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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。
器械摘要
Automated external defibrillators (non-wearable) 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 2026-07-30. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements.
常见问题
What is the Automated external defibrillators (non-wearable)?
Automated external defibrillators (non-wearable) is a medical device that received FDA 510(k) clearance on 2026-07-30. The listed applicant is Physio-Control, Inc..
When did Automated external defibrillators (non-wearable) receive FDA 510(k) clearance?
The clearance date for Automated external defibrillators (non-wearable) can be found in the official FDA records.
谁是自动体外除颤器（非穿戴式）的列名申请人？
The FDA 510(k) record lists Physio-Control, Inc. as the applicant. This does not by itself establish the device manufacturer.
什么是自动体外除颤器（非穿戴型）的FDA产品代码？
FDA产品代码为自动体外除颤器（非穿戴型）的是MKJ。这属于牙科类别。
相关临床试验
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。
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。
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