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FDA 510(k)

BioSticker System

K-Number: K191614 · 2019-12-18

ApplicantBiointellisense, Inc.
Decision Date2019-12-18
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BioSticker System is a medical device manufactured by Biointellisense, Inc.. It received FDA 510(k) clearance on 2019-12-18 under approval number K191614. 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 BioSticker System?

BioSticker System is a medical device that received FDA 510(k) clearance on 2019-12-18. It is manufactured by Biointellisense, Inc.. The 510(k) number is K191614.

When was BioSticker System approved by the FDA?

BioSticker System received FDA 510(k) clearance on 2019-12-18, under approval number K191614.

What company makes BioSticker System?

BioSticker System is manufactured by Biointellisense, Inc..

What is the FDA product code for BioSticker System?

The FDA product code for BioSticker System is DRG.

Other Devices by Biointellisense, Inc.

K241101BioButton System

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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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