Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K083697 |
Device Name |
FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M |
Applicant |
FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C |
REDMOND,
WA
98052 -4911
|
|
Applicant Contact |
DOUG BLAKELY |
Correspondent |
FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C |
REDMOND,
WA
98052 -4911
|
|
Correspondent Contact |
DOUG BLAKELY |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/15/2008 |
Decision Date | 03/19/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|