Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K023820 |
Device Name |
CO2 CLIP |
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 | 11/15/2002 |
Decision Date | 05/07/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|