The following data is part of a premarket notification filed by Drager Medical Ag & Co. Kgaa with the FDA for Option Smartcare For Evitaxl,smartcare Kit Capno Package, Co2 Sensor Capnosmart, Models 8415941, 8415942, 6871500.
| Device ID | K072412 |
| 510k Number | K072412 |
| Device Name: | OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | DRAGER MEDICAL AG & CO. KGAA 3135 Quarry Road Telford, PA 18969 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson DRAGER MEDICAL AG & CO. KGAA 3135 Quarry Road Telford, PA 18969 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-27 |
| Decision Date | 2008-02-06 |
| Summary: | summary |