Device Classification Name |
stethoscope, electronic
|
510(k) Number |
K121617 |
Device Name |
SENSICARDIAC |
Applicant |
DIACOUSTIC MEDICAL (PTY) |
1468 HARWELL AVE |
CROFTON,
MD
21114
|
|
Applicant Contact |
YOLANDA SMITH |
Correspondent |
DIACOUSTIC MEDICAL (PTY) |
1468 HARWELL AVE |
CROFTON,
MD
21114
|
|
Correspondent Contact |
YOLANDA SMITH |
Regulation Number | 870.1875
|
Classification Product Code |
|
Date Received | 06/01/2012 |
Decision Date | 07/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|