The following data is part of a premarket notification filed by Medical Electronic Systems, Ltd with the FDA for Yo Home Sperm Test.
| Device ID | K161493 |
| 510k Number | K161493 |
| Device Name: | YO Home Sperm Test |
| Classification | Semen Analysis Device |
| Applicant | MEDICAL ELECTRONIC SYSTEMS, LTD ALON HATAVOR ST.20 ZONE 6 Caesarea Ind. Park, IL 38900 |
| Contact | Marcia Deutsch |
| Correspondent | Erika Ammirati AMMIRATI REGULATORY CONSULTING 575 SHIRLYNN COURT Los Altos, CA 94022 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2016-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016650273 | K161493 | 000 |
| 07290016650365 | K161493 | 000 |
| 07290016650358 | K161493 | 000 |
| 07290016650341 | K161493 | 000 |