Examinetics, Inc. - Oct. 5, 2023
Issue Date
Oct 05, 2023
Region
Southwest
Category
Device
$117.00
Contact Name
Edward H. Stratemeier
Contact Title
Chief Technical Officer
Address 1
10561 Barkley St.
Address 2
Ste. 400
City
Overland Park
State
KS
Zip/Postal Code
66212-1836
Inspection Range
Oct 02, 2023 - Oct 05, 2023
Pages
4
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Eric C. Fox