The following data is part of a premarket notification filed by Cycle Clarity with the FDA for Follicle Clarity.
Device ID | K212012 |
510k Number | K212012 |
Device Name: | Follicle Clarity |
Classification | Automated Radiological Image Processing Software |
Applicant | Cycle Clarity 1209 Fifteen Mile Landing Rd. Awendaw, SC 29429 |
Contact | John Schnorr |
Correspondent | John Schnorr Cycle Clarity 1209 Fifteen Mile Landing Rd. Awendaw, SC 29429 |
Product Code | QIH |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-28 |
Decision Date | 2022-01-19 |