Advanced Monitored Caregiving - Dec. 13, 2011
Issue Date
Dec 13, 2011
Region
Northeast
Category
Device
$117.00
Address 1
11 John St.
Address 2
Ste. 250
City
New York
State
NY
Zip/Postal Code
10038
Country
US
Inspection Range
Dec 05, 2011 - Dec 13, 2011
Pages
4
First Observation
A device history record has not been maintained, procedures for design control have not been established and procedures for corrective and preventive action have not been established.
Investigator(s): Ronald Ifraimov