Sensomat
FDA 510(k) K771722 · Biochem International, Inc.
510(k) numberK771722
Submission
- Device name
- Sensomat
- Applicant
- Biochem International, Inc.
Mchenry, IL, US - Received
- September 13, 1977
- Decision date
- September 26, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Shiley, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K920083 | Biochem Model 3302 NEWOX2 OximeterDQA · Traditional | 04/11/1994SE |
| K932389 | 8100 Anesthetic Agent MonitorCBS · Traditional | 12/03/1993SE |
| K921388 | Biochem 9100 Multigas Monitor Ibp ModuleDSK · Traditional | 05/26/1993SE |
| K920082 | Biochem Model 3301 NEWOX1 OximeterDQA · Traditional | 01/07/1993SE |
| K911351 | Biochem 9100 Multigas Monitor TEMP/FIO1 Mod,NibpDXN · Traditional | 08/22/1991SE |
| K910381 | Biochem Temperature/ FIO2 ModuleCCL · Traditional | 08/22/1991SE |
| K903222 | Biochem 6100 Non-Invasive MonitorDXN · Traditional | 09/04/1990SE |
| K901861 | Biochem 9100 Multigas MonitorCCK · Traditional | 07/27/1990SE |
| K893877 | Biochem 3100 OximeterDQO · Traditional | 12/20/1989SE |
| K892646 | Biochem 8100 Anesthetic Agent MonitorCBQ · Traditional | 08/31/1989SE |
Questions and answers
When was Sensomat cleared by the FDA?
Sensomat (K771722) received a 510(k) decision of Substantially Equivalent on September 26, 1977, 13 days after the submission was received.
What is the product code of K771722?
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.