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FDA 510(k)

BioButton System

K-Number: K241101 · 2024-09-26

ApplicantBiointellisense, Inc.
Decision Date2024-09-26
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BioButton System is a medical device manufactured by Biointellisense, Inc.. It received FDA 510(k) clearance on 2024-09-26 under approval number K241101. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioButton System?

BioButton System is a medical device that received FDA 510(k) clearance on 2024-09-26. It is manufactured by Biointellisense, Inc.. The 510(k) number is K241101.

When was BioButton System approved by the FDA?

BioButton System received FDA 510(k) clearance on 2024-09-26, under approval number K241101.

What company makes BioButton System?

BioButton System is manufactured by Biointellisense, Inc..

What is the FDA product code for BioButton System?

The FDA product code for BioButton System is DRG.

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Official Source

View on FDA Database →

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