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510(k) K193330

Clue Birth Control by Biowink GmbH — Product Code PYT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 18, 2021
Date Received: December 2, 2019
Clearance Type: Abbreviated
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Device, Fertility Diagnostic, Contraceptive, Software Application
Device Class: Class II
Regulation Number: 884.5370
Review Panel: OB
Submission Type

Designed to monitor and provide fertility information to prevent pregnancy (contraception).