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 |