Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
FDA product code CCC · Class II (moderate risk) · 21 CFR 868.1150 · Anesthesiology
15510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K071165 | Iscalert Sensor SystemCCC · Traditional | Alertis Medical AS | 11/07/2007SE |
| K983198 | Trendcare Calibrator Model Scu 7007CCC · Traditional | Diametrics Medical, Ltd. | 11/23/1999SE |
| K972314 | Paratrend 7 Neotrend Multiparameter/Sensor with Paratrend 7 Multiparameter Senior and…CCC · Traditional | Diametrics Medical, Ltd. | 12/19/1997SE |
| K953893 | Paratrend 7 Intravascular Blood Gas Monitoring SystemCCC · Traditional | Biomedical Sensors, Inc. | 11/04/1997SE |
| K961790 | Point-Of-Care Blood Gas Monitor SystemCCC · Traditional | Optical Sensors, Inc. | 04/09/1997SE |
| K963935 | Olympus Critical Care Monitoring SystemCCC · Traditional | Optical Sensors, Inc. | 01/23/1997SE |
| K951094 | Point-Of-Care Arterial Blood Gas Monitoring SystemCCC · Traditional | Optical Sensors, Inc. | 01/16/1996SE |
| K940188 | Paratrend 7 Satellite Intravascular Blood Gas Monitoring SystemCCC · Traditional | Biomedical Sensors, Ltd. | 11/13/1995SE |
| K931185 | Sensicath Point-Of-Care Blood Gas Monitoring SysteCCC · Traditional | Optical Sensors, Inc. | 10/21/1993SE |
| K901548 | Biomedical Sensors-Shiley BGM 4000 Intra Blood GasCCC · Traditional | Shiley, Inc. | 01/14/1991SE |
| K891013 | Medtronic Intravascular Blood Gas MonitoringCCC · Traditional | Medtronic Vascular | 08/02/1989SE |
| K870911 | Indwelling Blood Carbondioxide Partial Pres. AnalyCCC · Traditional | American Bentley | 05/29/1987SE |
| K780185 | Oxygen Analyzer 110CCC · Traditional | Siemens Corp. | 03/17/1978SE |
| K771722 | SensomatCCC · Traditional | Biochem International, Inc. | 09/26/1977SE |
| K760088 | Analyzer, Sentorr Blood GasCCC · Traditional | Ohio Medical Products | 08/06/1976SE |