Sensomat
FDA 510(k) K803014 · Biochem International, Inc.
510(k) numberK803014
Submission
- Device name
- Sensomat
- Applicant
- Biochem International, Inc.
Mchenry, IL, US - Received
- November 28, 1980
- Decision date
- December 22, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBZ – Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1170
- Specialty
- Anesthesiology
Other 510(k)s with product code CBZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020967 | Terumo Khuri Myocardial PH Monitoring SystemCBZ · Traditional | Terumo Cardiovascular Systems Corp. | 06/20/2002SE |
| K970906 | Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus…CBZ · Traditional | Diametrics Medical, Ltd. | 09/23/1997SE |
| K931112 | Model PB3300 Intra-Arter Blood Gas Monit Sys, ModiCBZ · Traditional | Puritan Bennett Corp. | 06/01/1993SE |
| K920061 | Hemometrix Continuous Blood Gas Monitoring SystemCBZ · Traditional | Abbott Laboratories | 03/30/1992SE |
| K912030 | Cdi(Tm) 2000 Blood Gas Monitoring Syst, ModifiedCBZ · Traditional | 3M Company | 10/30/1991SE |
| K912428 | PB3300 Sensing Catheter for Continuous MeasurementCBZ · Traditional | Puritan Bennett Corp. | 08/09/1991SE |
| K884228 | Cdi(R) 2000 Blood Gas MonitorCBZ · Traditional | Cardiovascular Devices, Inc. | 01/30/1989SE |
| K862114 | Khuri Regional Tissue PH MonitorCBZ · Traditional | Vascular Technology Incorporated | 06/25/1986SE |
| K803260 | Sensomat Muscle/Tissue PHCBZ · Traditional | Biochem International, Inc. | 02/02/1981SE |
More from Biochem International, 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 (K803014) received a 510(k) decision of Substantially Equivalent on December 22, 1980, 24 days after the submission was received.
What is the product code of K803014?
The FDA product code is CBZ – Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1170.