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 |