Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K102376 |
Device Name |
NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201 |
Applicant |
NIHON KOHDEN CORP. |
90 ICON STREET |
FOOTHILL RANCH,
CA
92610
|
|
Applicant Contact |
STEVE GEERDES |
Correspondent |
NIHON KOHDEN CORP. |
90 ICON STREET |
FOOTHILL RANCH,
CA
92610
|
|
Correspondent Contact |
STEVE GEERDES |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 08/20/2010 |
Decision Date | 12/07/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|