The following data is part of a premarket notification filed by Thermo Electron Oy with the FDA for Dpc T60i Kusti, Model 984248; Dpc T60i, Model 984247.
| Device ID | K061107 |
| 510k Number | K061107 |
| Device Name: | DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | THERMO ELECTRON OY RATASTIE 2 Vantaa, FI 01620 |
| Contact | Paivi Sormunen |
| Correspondent | Paivi Sormunen THERMO ELECTRON OY RATASTIE 2 Vantaa, FI 01620 |
| Product Code | CEM |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-20 |
| Decision Date | 2006-08-08 |