自动体外除颤器（非穿戴）
PMA编号：P160026 · 2026-09-24
广告
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 2026-09-24. 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 2026-09-24. 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.
Who is the listed applicant for Automated external defibrillators (non-wearable)?
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 Automated external defibrillators (non-wearable)?
The FDA product code for Automated external defibrillators (non-wearable) is MKJ. This falls under the Dental category.
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。
广告