510(k) K923033
K923033 is an FDA 510(k) premarket notification submitted by Epm Information Systems, Inc. for the device "THE TRACKER". The FDA issued a decision of Substantially Equivalent on Jun 1, 1993. The device falls under product code LXJ (Interactive Rehabilitation Exercise Devices), a Class II device regulated under 21 CFR 890.5360. Epm Information Systems, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 1, 1993
- Date Received
- Mar 23, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interactive Rehabilitation Exercise Devices
- Device Class
- Class II
- Regulation Number
- 890.5360
- Review Panel
- PM
- Submission Type
- 510(k)