THE TRACKER

System, Optical Position/movement Recording

EPM INFORMATION SYSTEMS, INC.

The following data is part of a premarket notification filed by Epm Information Systems, Inc. with the FDA for The Tracker.

Pre-market Notification Details

• Device ID: K923033
• 510k Number: K923033
• Device Name: THE TRACKER
• Classification: System, Optical Position/movement Recording
• Applicant: EPM INFORMATION SYSTEMS, INC. 5212 HIGHBERRY WOODS RD. Midlothian, VA 23112
• Contact: Stephen A Burton
• Correspondent: Stephen A Burton; EPM INFORMATION SYSTEMS, INC. 5212 HIGHBERRY WOODS RD. Midlothian, VA 23112
• Product Code: LXJ
• CFR Regulation Number: 890.5360 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-03-23
• Decision Date: 1993-06-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05707480043477	K923033	000
05707480042500	K923033	000
05707480042548	K923033	000
05707480042555	K923033	000
05707480042609	K923033	000
05707480042661	K923033	000
05707480042685	K923033	000
05707480042715	K923033	000
05707480042807	K923033	000
05707480042838	K923033	000
05707480042272	K923033	000