510(k) K912428
- Device
- PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT
- Applicant
- PURITAN BENNETT CORP.
- 510(k) number
- K912428
- Product code
- CBZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-08-09
- Date received
- 1991-05-31
- Regulation
- 868.1170
- Classification name
- Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHAN NORSTED
- Address
- 6088 Corte Del Cedro Carlsbad CA US 92009 92009
FDA Registration Numbers#
- 3009673645
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CBZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020967 | TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM | Terumo Cardiovascular Systems Corp. | 2002-06-20 |
| K970906 | PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR | Diametrics Medical, Ltd. | 1997-09-23 |
| K931112 | MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI | Puritan Bennett Corp. | 1993-06-01 |
| K920061 | HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM | Abbott Laboratories | 1992-03-30 |
| K912030 | CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED | 3M Company | 1991-10-30 |
| K884228 | CDI(R) 2000 BLOOD GAS MONITOR | Cardiovascular Devices, Inc. | 1989-01-30 |
| K862114 | KHURI REGIONAL TISSUE PH MONITOR | Vascular Technology Incorporated | 1986-06-25 |
| K803260 | SENSOMAT MUSCLE/TISSUE PH | Biochem International, Inc. | 1981-02-02 |
| K803014 | SENSOMAT | Biochem International, Inc. | 1980-12-22 |
Legacy Summary#
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FDA Review#
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