The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Zinetics Composite Sensor Probe W/internal Ref..
| Device ID | K925405 |
| 510k Number | K925405 |
| Device Name: | ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. |
| Classification | Electrode, Ph, Stomach |
| Applicant | SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving, TX 75038 |
| Contact | Anna Pettersson |
| Correspondent | Anna Pettersson SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving, TX 75038 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-26 |
| Decision Date | 1994-09-30 |