Neuro Kinetics, Inc. - July 2, 2019
Issue Date
Jul 02, 2019
Region
Central
Category
Device
$117.00
Contact Name
Michael L. Saporito
Contact Title
CFO
Address 1
128 Gamma Dr.
City
Pittsburgh
State
PA
Zip/Postal Code
15238-2920
Country
United States
Inspection Range
Jun 17, 2019 - Jul 02, 2019
Pages
3
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Dennis Hock