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FDA PMA

電腦輔助個人化鎮靜系統

PMA 核准號:P080009 · 2016-03-15

決定日期2016-03-15
PMA 編號P080009
產品代碼PDR
器械分類3 類
醫療專科U
諮詢委員會AN

器材摘要

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.

常見問題

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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