The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Pb3200 Intra-arterial Blood Gas Monitoring System.
| Device ID | K905397 |
| 510k Number | K905397 |
| Device Name: | PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM |
| Classification | Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling |
| Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Contact | Marshall Smith |
| Correspondent | Marshall Smith PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Product Code | CCE |
| CFR Regulation Number | 868.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-30 |
| Decision Date | 1991-05-14 |