Device Classification Name |
Detector And Alarm, Arrhythmia
|
510(k) Number |
K000746 |
Device Name |
FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX |
Applicant |
FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C |
REDMOND,
WA
98052 -4911
|
|
Applicant Contact |
DAVID J GERAGHTY |
Correspondent |
FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C |
REDMOND,
WA
98052 -4911
|
|
Correspondent Contact |
DAVID J GERAGHTY |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 03/08/2000 |
Decision Date | 04/07/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|