Device Classification Name |
Semen Analysis Device
|
510(k) Number |
K220828 |
Device Name |
SQA-iO Sperm Quality Analyzer |
Applicant |
Medical Electronic Systems LTD |
Alon Hatavor 20, Zone 6, Caesarea Industrial Park |
Caesarea,
IL
3088900
|
|
Applicant Contact |
Marcia Deutsch |
Correspondent |
Medical Electronic Systems LTD |
Alon Hatavor 20, Zone 6, Caesarea Industrial Park |
Caesarea,
IL
3088900
|
|
Correspondent Contact |
Taly Vider Cohen |
Regulation Number | 864.5220 |
Classification Product Code |
|
Date Received | 03/22/2022 |
Decision Date | 08/07/2023 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|