Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K134046 |
Device Name |
FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR |
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 |
|
Date Received | 12/31/2013 |
Decision Date | 02/12/2015 |
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
|
|
|