NDS Surgical Imaging, LLC - March 25, 2015
Issue Date
Mar 25, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
Karim M. Khadr
Contact Title
President & General Manager
Address 1
5750 Hellyer Ave.
City
San Jose
State
CA
Zip/Postal Code
95138-1000
Country
United States
Inspection Range
Mar 23, 2015 - Mar 25, 2015
Pages
2
First Observation
When test/measurement equipment was found to not meet accuracy and precision limits, no action was taken to evaluate whether there was any adverse effect on the device's quality.
Investigator(s): Randall F. Albright, James D. Hildreth, and Phillip M. Pontikos