Issued: 12/22/11
Region: Northeast
Category: Device 483s
Inspection date range: 12/13/11-12/22/11
Pages: 2
Company: Biodex Medical Systems, Inc.
20 Ramsay Rd.
Shirley, NY 11967-4704
Inspector(s): Kwong P. Lee
Observations: The results of the evaluation of each event are not documented and maintained in the manufacturer’s MDR event file.
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