Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K171765 |
Device Name |
Nihon Kohden CO2 Monitor |
Applicant |
Nihon Kohden Corporation |
1-31-4 Nishiochiai, Shinjuku-Ku |
Tokyo,
JP
161-8560
|
|
Applicant Contact |
Thomas Bento |
Correspondent |
Nihon Kohden America, Inc. |
15353 Barranca Parkway |
Irvine,
CA
92618
|
|
Correspondent Contact |
Thomas Bento |
Regulation Number | 868.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/14/2017 |
Decision Date | 10/11/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|