The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Pb3300 Sensing Catheter For Continuous Measurement.
| Device ID | K912428 |
| 510k Number | K912428 |
| Device Name: | PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT |
| Classification | Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling |
| Applicant | PURITAN BENNETT CORP. 6088 CORTE DEL CEDRO Carlsbad, CA 92009 |
| Contact | Stephan Norsted |
| Correspondent | Stephan Norsted PURITAN BENNETT CORP. 6088 CORTE DEL CEDRO Carlsbad, CA 92009 |
| Product Code | CBZ |
| CFR Regulation Number | 868.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-31 |
| Decision Date | 1991-08-09 |