Clearance Summary
CODA MPX30 MOTION ANALYSIS SYSTEM received FDA 510(k) clearance under submission number K982425, sponsored by Pinsco Inc. Dba B & L Engineering. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1998-10-07.
- Submission: K982425
- Applicant / Sponsor: Pinsco Inc. Dba B & L Engineering
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5360
- Decision date: 1998-10-07
Classification & Regulation
This clearance is catalogued under FDA product code LXJ and 21 CFR 890.5360, within the Physical Medicine review panel as a Class II device.