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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 the device name listed in this FDA 510(k) record. The listed applicant is Biolntellisense, Inc.. It received FDA 510(k) clearance on 2022-12-12 under 510(k) 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. The listed applicant is Biolntellisense, Inc.. The 510(k) number is K212957.

When did BioButton System receive FDA 510(k) clearance?

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

Who is the listed applicant for BioButton System?

The FDA 510(k) record lists Biolntellisense, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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