The following data is part of a premarket notification filed by Radiometer Basel Ag with the FDA for Tosca 500 Tcpco2, Spo2 And Pulse Rate Monitoring System.
| Device ID | K063434 |
| 510k Number | K063434 |
| Device Name: | TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM |
| Classification | Oximeter |
| Applicant | RADIOMETER BASEL AG AUSTRASSE 25 Basel, CH 4051 |
| Contact | Jean-pierre Palma |
| Correspondent | Jean-pierre Palma RADIOMETER BASEL AG AUSTRASSE 25 Basel, CH 4051 |
| Product Code | DQA |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | LKD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-13 |
| Decision Date | 2007-01-22 |
| Summary: | summary |