Cdi(Tm) 2000 Blood Gas Monitoring Syst, Modified
FDA 510(k) K912030 · 3M Company
510(k) numberK912030
Submission
- Device name
- Cdi(Tm) 2000 Blood Gas Monitoring Syst, Modified
- Applicant
- 3M Company
Tustin, CA, US - Received
- May 7, 1991
- Decision date
- October 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K803014 | SensomatCBZ · Traditional | Biochem International, Inc. | 12/22/1980SE |
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Questions and answers
When was Cdi(Tm) 2000 Blood Gas Monitoring Syst, Modified cleared by the FDA?
Cdi(Tm) 2000 Blood Gas Monitoring Syst, Modified (K912030) received a 510(k) decision of Substantially Equivalent on October 30, 1991, 176 days after the submission was received.
What is the product code of K912030?
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.