Infraredx, Inc. - 11/15/2012
Issue Date
Nov 15, 2012
Region
Northeast
Category
Device
$117.00
Address 1
34 3rd Ave
City
Burlington
State
MA
Zip/Postal Code
01803
Country
United States
Inspection Range
Nov 13, 2012 - Nov 15, 2012
Pages
2
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 may have caused or contributed to a death or serious injury.
Investigator(s): John A. Sciacchitano