Device Classification Name |
electrocardiograph, ambulatory (without analysis)
|
510(k) Number |
K062959 |
Device Name |
DMS 300-2, 300-3 AND 300-4 |
Applicant |
DIAGNOSTIC MONITORING SOFTWARE |
292 KINGSBURY GRADE, #32 |
P.O. BOX 3109 |
STATELINE,
NV
89449
|
|
Applicant Contact |
WILLIAM PARSONS |
Correspondent |
DIAGNOSTIC MONITORING SOFTWARE |
292 KINGSBURY GRADE, #32 |
P.O. BOX 3109 |
STATELINE,
NV
89449
|
|
Correspondent Contact |
WILLIAM PARSONS |
Regulation Number | 870.2800
|
Classification Product Code |
|
Date Received | 09/29/2006 |
Decision Date | 10/16/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|