Neurowave Systems, Inc. - Feb. 3, 2015
Issue Date
Feb 03, 2015
Region
Central
Category
Device
$117.00
Contact Name
Tatjana Zikov
Contact Title
President
Address 1
2490 Lee Blvd.
Address 2
Ste. 300
City
Cleveland Heights
State
OK
Zip/Postal Code
44119-1268
Country
United States
Inspection Range
Jan 23, 2015 - Feb 03, 2015
Pages
3
First Observation
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Benjamin J. Dastoli