Device Classification Name |
Electrocardiograph, Ambulatory (Without Analysis)
|
510(k) Number |
K041901 |
Device Name |
SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER |
Applicant |
NORTHEAST MONITORING, INC. |
543 LONG HILL AVENUE |
SHELTON,
CT
06484
|
|
Applicant Contact |
JOSEPH AZARY |
Correspondent |
NORTHEAST MONITORING, INC. |
543 LONG HILL AVENUE |
SHELTON,
CT
06484
|
|
Correspondent Contact |
JOSEPH AZARY |
Regulation Number | 870.2800
|
Classification Product Code |
|
Date Received | 07/14/2004 |
Decision Date | 08/31/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|