510(k) K982425
K982425 is an FDA 510(k) premarket notification submitted by Pinsco Inc. Dba B & L Engineering for the device "CODA MPX30 MOTION ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on Oct 7, 1998. The device falls under product code LXJ (Interactive Rehabilitation Exercise Devices), a Class II device regulated under 21 CFR 890.5360. Pinsco Inc. Dba B & L Engineering has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 7, 1998
- Date Received
- Jul 13, 1998
- 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)