Device Classification Name |
semen analysis device
|
510(k) Number |
K161493 |
Device Name |
YO Home Sperm Test |
Applicant |
MEDICAL ELECTRONIC SYSTEMS, LTD |
ALON HATAVOR ST.20 |
ZONE 6 |
CAESAREA IND. PARK,
IL
38900
|
|
Applicant Contact |
MARCIA DEUTSCH |
Correspondent |
AMMIRATI REGULATORY CONSULTING |
575 SHIRLYNN COURT |
LOS ALTOS,
CA
94022
|
|
Correspondent Contact |
Erika Ammirati |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 06/01/2016 |
Decision Date | 11/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|