Smart Medical Technology, Inc. - 12/17/2013
Issue Date
Dec 17, 2013
Region
Central
Category
Device
$117.00
Address 1
8404 Wilmette Avenue
Address 2
Suite B
City
Darien
State
IL
Zip/Postal Code
60561-6425
Country
United States
Inspection Range
Dec 16, 2013 - Dec 17, 2013
Pages
2
First Observation
Results of the design risk analysis were not adequately documented.
Investigator(s): Kimberly Lewandowski-Walker