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FDA 510(k)

Bonus Therapeutics Mixing and Delivery System

K-Number: K190996 · 2019-07-28

ApplicantBonus Therapeutics , Ltd.
Decision Date2019-07-28
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Bonus Therapeutics Mixing and Delivery System is a medical device manufactured by Bonus Therapeutics , Ltd.. It received FDA 510(k) clearance on 2019-07-28 under approval number K190996. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bonus Therapeutics Mixing and Delivery System?

Bonus Therapeutics Mixing and Delivery System is a medical device that received FDA 510(k) clearance on 2019-07-28. It is manufactured by Bonus Therapeutics , Ltd.. The 510(k) number is K190996.

When was Bonus Therapeutics Mixing and Delivery System approved by the FDA?

Bonus Therapeutics Mixing and Delivery System received FDA 510(k) clearance on 2019-07-28, under approval number K190996.

What company makes Bonus Therapeutics Mixing and Delivery System?

Bonus Therapeutics Mixing and Delivery System is manufactured by Bonus Therapeutics , Ltd..

What is the FDA product code for Bonus Therapeutics Mixing and Delivery System?

The FDA product code for Bonus Therapeutics Mixing and Delivery System is FMF.

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Related PubMed Literature

PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026)

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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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