The following data is part of a premarket notification filed by Mui Scientific with the FDA for Motility Catheters.
| Device ID | K823701 |
| 510k Number | K823701 |
| Device Name: | MOTILITY CATHETERS |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | MUI SCIENTIFIC 2570 HAINES RD., UNIT #1 Mississauga, Ontario, CA L4y 4a3 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-08 |
| Decision Date | 1983-02-15 |