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FDA PMA

计算机辅助个性化镇静系统

PMA编号:P080009 · 2016-03-15

决定日期2016-03-15
PMA 编号P080009
产品代码PDR
设备分类第3类
医疗专科U
咨询委员会AN 请注意,由于您没有提供完整的医疗设备监管文本,我无法提供完整的翻译。如果您能提供完整的文本,我将很乐意为您翻译。

器械摘要

Computer-assisted personalized sedation system is the device name listed in this FDA 510(k) record. The listed applicant is Scott Laboratories, Inc.. It received FDA 510(k) clearance on 2016-03-15. The device is classified under product code PDR. It was reviewed by the AN advisory panel.

常见问题

What is the Computer-assisted personalized sedation system?

Computer-assisted personalized sedation system is a medical device that received FDA 510(k) clearance on 2016-03-15. The listed applicant is Scott Laboratories, Inc..

When did Computer-assisted personalized sedation system receive FDA 510(k) clearance?

The clearance date for Computer-assisted personalized sedation system can be found in the official FDA records.

Who is the listed applicant for Computer-assisted personalized sedation system?

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

What is the FDA product code for Computer-assisted personalized sedation system?

The FDA product code for Computer-assisted personalized sedation system is PDR.

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