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FDA 510(k)

Clue Birth Control

K-Number: K193330 · 2021-02-18

ApplicantBiowink GmbH
Decision Date2021-02-18
Product CodePYT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Clue Birth Control is a medical device manufactured by Biowink GmbH. It received FDA 510(k) clearance on 2021-02-18 under approval number K193330. The device is classified under product code PYT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clue Birth Control?

Clue Birth Control is a medical device that received FDA 510(k) clearance on 2021-02-18. It is manufactured by Biowink GmbH. The 510(k) number is K193330.

When was Clue Birth Control approved by the FDA?

Clue Birth Control received FDA 510(k) clearance on 2021-02-18, under approval number K193330.

What company makes Clue Birth Control?

Clue Birth Control is manufactured by Biowink GmbH.

What is the FDA product code for Clue Birth Control?

The FDA product code for Clue Birth Control is PYT.

Related Clinical Trials

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Related PubMed Literature

PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

Related Devices (Code: PYT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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