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 |