The following data is part of a premarket notification filed by Motilitycount Aps with the FDA for Swimcount Sperm Quality Test.
| Device ID | K183602 |
| 510k Number | K183602 |
| Device Name: | SwimCount Sperm Quality Test |
| Classification | Semen Analysis Device |
| Applicant | MotilityCount ApS G1. Koge Landevej 55 Valby, DK Dk-2500 |
| Contact | Jacob Mollenbach |
| Correspondent | Jacob Mollenbach MotilityCount ApS G1. Koge Landevej 55 Valby, DK Dk-2500 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-06-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843277100048 | K183602 | 000 |