The following data is part of a premarket notification filed by Linde Medical Sensors Ag with the FDA for Tosca Pco2, Spo2 And Pulse Rate Monitoring System.
| Device ID | K032291 |
| 510k Number | K032291 |
| Device Name: | TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM |
| Classification | Radioimmunoassay, Digoxin (125-i), Goat Antibody, Anion Exchange, Resin Sep. |
| Applicant | LINDE MEDICAL SENSORS AG AUSTRASSE 25 Basel, CH Ch-4051 |
| Contact | Jean-pierre Palma |
| Correspondent | Jean-pierre Palma LINDE MEDICAL SENSORS AG AUSTRASSE 25 Basel, CH Ch-4051 |
| Product Code | DOA |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-24 |
| Decision Date | 2004-08-24 |
| Summary: | summary |