Biodex Medical Systems, Inc. - June 20, 2013
Issue Date
Jun 20, 2013
Region
Northeast
Category
Device
$117.00
Contact Name
Julia Dzakonski
Contact Title
Quality Assurance Manager
Address 1
20 Ramsay Rd.
City
Shirley
State
NY
Zip/Postal Code
11967-4704
Country
United States
Inspection Range
Jun 07, 2013 - Jun 20, 2013
Pages
3
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): Kwong Lee