The following data is part of a premarket notification filed by Pinsco Inc. Dba B & L Engineering with the FDA for Coda Mpx30 Motion Analysis System.
| Device ID | K982425 |
| 510k Number | K982425 |
| Device Name: | CODA MPX30 MOTION ANALYSIS SYSTEM |
| Classification | Interactive Rehabilitation Exercise Devices |
| Applicant | PINSCO INC. DBA B & L ENGINEERING 3002 DOW AVENUE, SUITE 416 Tustin, CA 92780 |
| Contact | Lee A Barnes |
| Correspondent | Lee A Barnes PINSCO INC. DBA B & L ENGINEERING 3002 DOW AVENUE, SUITE 416 Tustin, CA 92780 |
| Product Code | LXJ |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-13 |
| Decision Date | 1998-10-07 |
| Summary: | summary |