Monteris Medical Corp. - Oct. 14, 2018
Issue Date
Oct 04, 2018
Region
Central
Category
Device
$117.00
Contact Name
Martin J. Emerson
Contact Title
President and CEO
Address 1
14755 27th Ave. N
Address 2
Ste. C
City
Plymouth
State
MN
Zip/Postal Code
55447-4866
Country
United States
Inspection Range
Sep 20, 2018 - Oct 04, 2018
Pages
3
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Susan M. Matthias