The following data is part of a premarket notification filed by Natural Cycles Nordic Ab with the FDA for Natural Cycles.
| Device ID | K202897 |
| 510k Number | K202897 |
| Device Name: | Natural Cycles |
| Classification | Device, Fertility Diagnostic, Contraceptive, Software Application |
| Applicant | Natural Cycles Nordic AB St Eriksgatan 63b Stockholm, SE 112 34 |
| Contact | Raoul Scherwitzl |
| Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002 |
| Product Code | PYT |
| CFR Regulation Number | 884.5370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2021-06-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NATURAL CYCLES 90379477 not registered Live/Pending |
NaturalCycles Nordic AB 2020-12-14 |
![]() NATURAL CYCLES 90379473 not registered Live/Pending |
NaturalCycles Nordic AB 2020-12-14 |