The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Capnostat / Capnoflex Co2 System.
| Device ID | K083750 |
| 510k Number | K083750 |
| Device Name: | CAPNOSTAT / CAPNOFLEX CO2 SYSTEM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Robert L Casarsa |
| Correspondent | Robert L Casarsa GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | MHX |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DQK |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DXN |
| Subsequent Product Code | GWQ |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-17 |
| Decision Date | 2009-03-23 |
| Summary: | summary |