The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Synectics Ph Sys Comprising Digitrapper Mark Ii, E.
| Device ID | K850361 |
| 510k Number | K850361 |
| Device Name: | SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E |
| Classification | Electrode, Ph, Stomach |
| Applicant | SYNECTICS-DANTEC 333 N. MICHIGAN AVE. #2315 Chicago, IL 60601 |
| Contact | Anders Essen-moller |
| Correspondent | Anders Essen-moller SYNECTICS-DANTEC 333 N. MICHIGAN AVE. #2315 Chicago, IL 60601 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-30 |
| Decision Date | 1985-05-01 |