The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Digitrapper Mark Iii.
| Device ID | K913387 |
| 510k Number | K913387 |
| Device Name: | DIGITRAPPER MARK III |
| Classification | Electrode, Ph, Stomach |
| Applicant | SYNECTICS-DANTEC RENSTIENAS GATA 12, 5TR. S-116 28 STOCKHOLM Sweden, SE S-116 28 |
| Contact | Anna Pettersson |
| Correspondent | Anna Pettersson SYNECTICS-DANTEC RENSTIENAS GATA 12, 5TR. S-116 28 STOCKHOLM Sweden, SE S-116 28 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-29 |
| Decision Date | 1991-12-27 |