Non-Invasive Monitoring Systems, Inc.
Issue Date
Mar 25, 2010
Region
Southeast
Category
Device
$117.00
Address 1
4400 Biscayne Blvd.
City
Miami
State
FL
Zip/Postal Code
33137
Country
US
Inspection Range
Mar 24, 2010 - Mar 25, 2010
Pages
3
First Observation
Procedures to ensure that a device's design input requirements are appropriate and address its intended use, including user/patient needs, were not implemented.
Investigator(s): Richard K. Vogel