Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K151080 |
Device Name |
Nihon Kohden CSM 1901 Bedside Monitor |
Applicant |
Nihon Kohden |
15353 Barranca Parkway |
Irvine,
CA
92618
|
|
Applicant Contact |
Tom Bento |
Correspondent |
CERTIFIED COMPLIANCE SOLUTIONS, INC. |
11665 AVENA PLACE, SUITE 203 |
SAN DIEGO,
CA
92128
|
|
Correspondent Contact |
Al Pacheco |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 04/22/2015 |
Decision Date | 11/05/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|