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 |