Device Classification Name |
electrocardiograph
|
510(k) Number |
K090367 |
Device Name |
SE-601 SERIES ELECTROCARDIOGRAPH |
Applicant |
EDAN INSTRUMENTS, INC. |
1 ODELL PLAZA |
YONKERS,
NY
10701
|
|
Applicant Contact |
WILLIAM STERN |
Correspondent |
EDAN INSTRUMENTS, INC. |
1 ODELL PLAZA |
YONKERS,
NY
10701
|
|
Correspondent Contact |
WILLIAM STERN |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 02/13/2009 |
Decision Date | 06/03/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|