Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K131045 |
Device Name |
ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE |
Applicant |
CARDIAC DESIGNS, LLC |
57 LAZY BROOK RD |
MONROE,
CT
06468
|
|
Applicant Contact |
RAYMOND J KELLY, IV |
Correspondent |
CARDIAC DESIGNS, LLC |
57 LAZY BROOK RD |
MONROE,
CT
06468
|
|
Correspondent Contact |
RAYMOND J KELLY, IV |
Regulation Number | 870.1425
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/15/2013 |
Decision Date | 05/29/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|