Device Classification Name |
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
|
510(k) Number |
K832655 |
Device Name |
ECOLYZER #200/COHB ANALYZER SYS |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Regulation Number | 868.1430
|
Classification Product Code |
|
Date Received | 08/08/1983 |
Decision Date | 09/26/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|