Device Classification Name |
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
|
510(k) Number |
K931112 |
Device Name |
MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI |
Applicant |
PURITAN BENNETT CORP. |
6088 CORTE DEL CEDRO |
CARLSBAD,
CA
92009
|
|
Applicant Contact |
WILLIAM M TOWNSEND |
Correspondent |
PURITAN BENNETT CORP. |
6088 CORTE DEL CEDRO |
CARLSBAD,
CA
92009
|
|
Correspondent Contact |
WILLIAM M TOWNSEND |
Regulation Number | 868.1170
|
Classification Product Code |
|
Date Received | 03/04/1993 |
Decision Date | 06/01/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|