Device Classification Name |
stethoscope, electronic
|
510(k) Number |
K173663 |
Device Name |
Electronic Stethoscope DS3011A |
Applicant |
IMEDIPLUS INC. |
2F, 12, Shengyi Rd.Sec.2 |
Chupei City,
TW
30261
|
|
Applicant Contact |
Shirley Lai |
Correspondent |
IMEDIPLUS INC. |
2F, 12, Shengyi Rd.Sec.2 |
Chupei City,
TW
30261
|
|
Correspondent Contact |
Shirley Lai |
Regulation Number | 870.1875
|
Classification Product Code |
|
Date Received | 11/29/2017 |
Decision Date | 08/17/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|