Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
The Indwelling Blood-Phase Carbon-Dioxide Partial Pressure Analyzer is an anesthesiology device that measures the partial pressure of carbon dioxide (pCO2) directly within the bloodstream on a continuous basis, enabling real-time respiratory and metabolic monitoring without repeated blood draws. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CCC, regulated under 21 CFR 868.1150, within the Anesthesiology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- CCC
- Device Class
- FDA class 2
- Regulation Number
- 868.1150
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K071165 | ISCALERT SENSOR SYSTEM | Nov 07, 2007 | Substantially Equivalent | Alertis Medical AS |
| K983198 | TRENDCARE CALIBRATOR MODEL SCU 7007 | Nov 23, 1999 | Substantially Equivalent | Diametrics Medical, Ltd. |
| K972314 | PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM | Dec 19, 1997 | Substantially Equivalent | Diametrics Medical, Ltd. |
| K953893 | PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM | Nov 04, 1997 | Substantially Equivalent | Biomedical Sensors, Inc. |
| K961790 | POINT-OF-CARE BLOOD GAS MONITOR SYSTEM | Apr 09, 1997 | Substantially Equivalent | Optical Sensors, Inc. |
| K963935 | OLYMPUS CRITICAL CARE MONITORING SYSTEM | Jan 23, 1997 | Substantially Equivalent | Optical Sensors, Inc. |
| K951094 | POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM | Jan 16, 1996 | Substantially Equivalent | Optical Sensors, Inc. |
| K940188 | PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM | Nov 13, 1995 | Substantially Equivalent | Biomedical Sensors, Ltd. |
| K931185 | SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE | Oct 21, 1993 | Substantially Equivalent | Optical Sensors, Inc. |
| K901548 | BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS | Jan 14, 1991 | Substantially Equivalent | Shiley, Inc. |
| K891013 | MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING | Aug 02, 1989 | Substantially Equivalent | Medtronic Vascular |
| K870911 | INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY | May 29, 1987 | Substantially Equivalent | American Bentley |
| K780185 | OXYGEN ANALYZER 110 | Mar 17, 1978 | Substantially Equivalent | Siemens Corp. |
| K771722 | SENSOMAT | Sep 26, 1977 | Substantially Equivalent | Biochem International, Inc. |
| K760088 | ANALYZER, SENTORR BLOOD GAS | Aug 06, 1976 | Substantially Equivalent | Ohio Medical Products |