PB3300 Sensing Catheter for Continuous Measurement
FDA 510(k) K912428 · Puritan Bennett Corp.
510(k) numberK912428
Submission
- Device name
- PB3300 Sensing Catheter for Continuous Measurement
- Applicant
- Puritan Bennett Corp.
Carlsbad, CA, US - Received
- May 31, 1991
- Decision date
- August 9, 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
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|---|---|---|---|
| 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 |
| 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 PB3300 Sensing Catheter for Continuous Measurement cleared by the FDA?
PB3300 Sensing Catheter for Continuous Measurement (K912428) received a 510(k) decision of Substantially Equivalent on August 9, 1991, 70 days after the submission was received.
What is the product code of K912428?
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.