The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Model Pb3300 Intra-arter Blood Gas Monit Sys, Modi.
Device ID | K931112 |
510k Number | K931112 |
Device Name: | MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI |
Classification | Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling |
Applicant | PURITAN BENNETT CORP. 6088 CORTE DEL CEDRO Carlsbad, CA 92009 |
Contact | William M Townsend |
Correspondent | William M Townsend 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 | 1993-03-04 |
Decision Date | 1993-06-01 |