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FDA 510(k)

BioButton System

K-Number: K212957 · 2022-12-12

ApplicantBiolntellisense, Inc.
Decision Date2022-12-12
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BioButton System is a medical device manufactured by Biolntellisense, Inc.. It received FDA 510(k) clearance on 2022-12-12 under approval number K212957. 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 2022-12-12. It is manufactured by Biolntellisense, Inc.. The 510(k) number is K212957.

When was BioButton System approved by the FDA?

BioButton System received FDA 510(k) clearance on 2022-12-12, under approval number K212957.

What company makes BioButton System?

BioButton System is manufactured by Biolntellisense, 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

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