The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Trusignal Spo2 Fingertip Sensor.
| Device ID | K101871 |
| 510k Number | K101871 |
| Device Name: | TRUSIGNAL SPO2 FINGERTIP 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-06 |
| Decision Date | 2010-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103329 | K101871 | 000 |
| 00840682103237 | K101871 | 000 |