Q.I. Medical, Inc. - 12/18/2012
Issue Date
Dec 18, 2012
Region
Pacific
Category
Device
$117.00
Address 1
440 Lower Grass Valley Road
Address 2
Suite C
City
Nevada City
State
CA
Zip/Postal Code
95959
Country
United States
Inspection Range
Dec 17, 2012 - Dec 18, 2012
Pages
2
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Seema S. Singh