Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus Multiparameter Sensor
FDA 510(k) K970906 · Diametrics Medical, Ltd.
510(k) numberK970906
Submission
- Device name
- Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus Multiparameter Sensor
- Applicant
- Diametrics Medical, Ltd.
High Wycombe, Buckinghamshire, GB - Received
- March 12, 1997
- Decision date
- September 23, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| 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 |
| K803014 | SensomatCBZ · Traditional | Biochem International, Inc. | 12/22/1980SE |
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Questions and answers
When was Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus Multiparameter Sensor cleared by the FDA?
Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus Multiparameter Sensor (K970906) received a 510(k) decision of Substantially Equivalent on September 23, 1997, 195 days after the submission was received.
What is the product code of K970906?
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.