The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Trusignal Spo2 Finger Sensor, Trusignal Spo2 Ear Sensor, Trusignal Spo2 Wrap Sensor.
| Device ID | K093881 |
| 510k Number | K093881 |
| Device Name: | TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR |
| Classification | Oximeter |
| Applicant | GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Contact | Tommi Jokiniemi |
| Correspondent | Tommi Jokiniemi GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-18 |
| Decision Date | 2010-03-12 |
| Summary: | summary |