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 |