The following data is part of a premarket notification filed by Linde Medical Sensors Ag with the FDA for Tosca 500 Pco2, Spo2 And Pulse Rate Monitoring System, Model 5202009.
| Device ID | K043357 |
| 510k Number | K043357 |
| Device Name: | TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 |
| Classification | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | LINDE MEDICAL SENSORS AG AUSTRASSE 25 Basel, CH 4051 |
| Contact | Jean-pierre Palma |
| Correspondent | Jean-pierre Palma LINDE MEDICAL SENSORS AG AUSTRASSE 25 Basel, CH 4051 |
| Product Code | LKD |
| CFR Regulation Number | 868.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-06 |
| Decision Date | 2005-03-04 |
| Summary: | summary |