The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Synectics Motility System.
| Device ID | K862929 |
| 510k Number | K862929 |
| Device Name: | SYNECTICS MOTILITY SYSTEM |
| Classification | Electrode, Ph, Stomach |
| Applicant | SYNECTICS-DANTEC 3710 WEST PIERCE ST. Milwaukee, WI 53215 |
| Contact | Tord Lendau |
| Correspondent | Tord Lendau SYNECTICS-DANTEC 3710 WEST PIERCE ST. Milwaukee, WI 53215 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-23 |
| Decision Date | 1986-10-20 |