Device Classification Name |
stethoscope, electronic
|
510(k) Number |
K160023 |
Device Name |
Electronic Stethoscope DS301 |
Applicant |
IMEDIPLUS INC. |
2F, 12, SHENGYI RD.SEC.2 |
CHUBEI CITY,
TW
30261
|
|
Applicant Contact |
SHIRLEY LAI |
Correspondent |
IMEDIPLUS INC. |
2F, 12, SHENGYI RD.SEC.2 |
CHUBEI CITY,
TW
30261
|
|
Correspondent Contact |
SHIRLEY LAI |
Regulation Number | 870.1875
|
Classification Product Code |
|
Date Received | 01/06/2016 |
Decision Date | 09/30/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|