Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K921497 |
Device Name |
PROPAQ MONITORS, MODIFICATION |
Applicant |
PROTOCOL SYSTEMS, INC. |
8500 S.W. CREEKSIDE PLACE |
BEAVERTON,
OR
97008 -7101
|
|
Applicant Contact |
JAMES W SANDBERG |
Correspondent |
PROTOCOL SYSTEMS, INC. |
8500 S.W. CREEKSIDE PLACE |
BEAVERTON,
OR
97008 -7101
|
|
Correspondent Contact |
JAMES W SANDBERG |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 03/11/1992 |
Decision Date | 03/23/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|