Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase
|
510(k) Number |
K000520 |
Device Name |
C-IT |
Applicant |
BREGAS AB |
ULVSUNDAVAGEN 178B |
BROMMA,
SE
SE-16867
|
|
Applicant Contact |
PAUL KRILL |
Correspondent |
BREGAS AB |
ULVSUNDAVAGEN 178B |
BROMMA,
SE
SE-16867
|
|
Correspondent Contact |
PAUL KRILL |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 02/16/2000 |
Decision Date | 05/16/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|