The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Trusignal R Spo2 Peditip Sensor; Trusignal R Spo2 Peditip Sensor; Trusignal R Spo2 Peditip Sensor.
| Device ID | K103802 |
| 510k Number | K103802 |
| Device Name: | TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR |
| Classification | Oximeter |
| Applicant | GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Contact | Tatja Pasanen |
| Correspondent | Tatja Pasanen GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-28 |
| Decision Date | 2011-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103411 | K103802 | 000 |
| 00840682103404 | K103802 | 000 |