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FDA PMA

Computer-assisted personalized sedation system

PMA Number: P080009 · 2016-03-15

ApplicantScott Laboratories, Inc.
Decision Date2016-03-15
PMA NumberP080009
Product CodePDR
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeAN

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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