510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PDRClass III

Computer-Assisted Personalized Sedation System

Unknown
FDA source (opens on fda.gov)

PDR is the FDA product code for Computer-Assisted Personalized Sedation System, a class III device type. FDA's definition for this code reads: "Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
PDR
Device name
Computer-Assisted Personalized Sedation System
FDA definition
Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PDR.