Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K983928 |
Device Name |
KODAK HOME HEALTH MONITORING SYSTEM |
Applicant |
EASTMAN KODAK COMPANY |
901 ELMGROVE RD. |
ROCHESTER,
NY
14653 -4757
|
|
Applicant Contact |
JUDITH A WALLACE |
Correspondent |
EASTMAN KODAK COMPANY |
901 ELMGROVE RD. |
ROCHESTER,
NY
14653 -4757
|
|
Correspondent Contact |
JUDITH A WALLACE |
Regulation Number | 870.2300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/05/1998 |
Decision Date | 02/11/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|