Point-Of-Care Blood Gas Monitor System
FDA 510(k) K961790 · Optical Sensors, Inc.
510(k) numberK961790
Submission
- Device name
- Point-Of-Care Blood Gas Monitor System
- Applicant
- Optical Sensors, Inc.
Eden Prairie, MN, US - Received
- May 9, 1996
- Decision date
- April 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCC – Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1150
- Specialty
- Anesthesiology
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| 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 |
| 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 |
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| K040654 | Sensilase Pad 3000DPW · Abbreviated | 06/04/2004SE |
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| K963935 | Olympus Critical Care Monitoring SystemCCC · Traditional | 01/23/1997SE |
| K951094 | Point-Of-Care Arterial Blood Gas Monitoring SystemCCC · Traditional | 01/16/1996SE |
| K931185 | Sensicath Point-Of-Care Blood Gas Monitoring SysteCCC · Traditional | 10/21/1993SE |
Questions and answers
When was Point-Of-Care Blood Gas Monitor System cleared by the FDA?
Point-Of-Care Blood Gas Monitor System (K961790) received a 510(k) decision of Substantially Equivalent on April 9, 1997, 335 days after the submission was received.
What is the product code of K961790?
The FDA product code is CCC – Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1150.