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
|
|
|