I.T.S. GmbH - May 3, 2019
Issue Date
May 03, 2019
Region
HQ
Category
Device
$117.00
Contact Name
Wolfgang Auf
Contact Title
CEO
Address 1
Autal 28
City
Lassnitzhoehea
State
Styria
Zip/Postal Code
8301
Country
Austria
Inspection Range
Apr 29, 2019 - May 03, 2019
Pages
3
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of
information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Investigator(s): Stephen R. Souza