Criticare Technologies, Inc. - March 29, 2017
Issue Date
Mar 29, 2017
Region
Northeast
Category
Device
$117.00
Contact Name
Neeraj Jha
Contact Title
CEO
Address 1
125 Commerce Park Rd.
City
North Kingstown
State
RI
Zip/Postal Code
02852
Country
United States
Inspection Range
Mar 06, 2017 - Mar 29, 2017
Pages
9
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 has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Maryam Tabatabaie