510(k) K961790
- Device
- POINT-OF-CARE BLOOD GAS MONITOR SYSTEM
- Applicant
- OPTICAL SENSORS, INC.
- 510(k) number
- K961790
- Product code
- CCC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-09
- Date received
- 1996-05-09
- Regulation
- 868.1150
- Classification name
- Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DENISE A SSCHOTTLER
- Address
- 7615 Golden Triangle Dr., Suite A Eden Prairie MN US 55344 55344
Source Documents#
Other 510(k) Records For Product Code CCC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K071165 | ISCALERT SENSOR SYSTEM | Alertis Medical AS | 2007-11-07 |
| K983198 | TRENDCARE CALIBRATOR MODEL SCU 7007 | Diametrics Medical, Ltd. | 1999-11-23 |
| K972314 | PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM | Diametrics Medical, Ltd. | 1997-12-19 |
| K953893 | PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM | Biomedical Sensors, Inc. | 1997-11-04 |
| K963935 | OLYMPUS CRITICAL CARE MONITORING SYSTEM | Optical Sensors, Inc. | 1997-01-23 |
| K951094 | POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM | Optical Sensors, Inc. | 1996-01-16 |
| K940188 | PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM | Biomedical Sensors, Ltd. | 1995-11-13 |
| K931185 | SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE | Optical Sensors, Inc. | 1993-10-21 |
| K901548 | BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS | Shiley, Inc. | 1991-01-14 |
| K891013 | MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING | Medtronic Vascular | 1989-08-02 |
| K870911 | INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY | American Bentley | 1987-05-29 |
| K780185 | OXYGEN ANALYZER 110 | Siemens Corp. | 1978-03-17 |
| K771722 | SENSOMAT | Biochem International, Inc. | 1977-09-26 |
| K760088 | ANALYZER, SENTORR BLOOD GAS | Ohio Medical Products | 1976-08-06 |
Legacy Summary#
summary
FDA Review#
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