Device Classification Name |
Stethoscope, Electronic
|
510(k) Number |
K131044 |
Device Name |
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION |
Applicant |
DIACOUSTIC MEDICAL DEVICES (PTY) LTD. |
1468 Harwell Avenue |
Crofton,
MD
21114
|
|
Applicant Contact |
YOLANDA SMITH |
Correspondent |
DIACOUSTIC MEDICAL DEVICES (PTY) LTD. |
1468 Harwell Avenue |
Crofton,
MD
21114
|
|
Correspondent Contact |
YOLANDA SMITH |
Regulation Number | 870.1875
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/15/2013 |
Decision Date | 09/04/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|