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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 the device name listed in this FDA 510(k) record. The listed applicant is Biointellisense, Inc.. It received FDA 510(k) clearance on 2019-12-18 under 510(k) 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. The listed applicant is Biointellisense, Inc.. The 510(k) number is K191614.

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

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

Who is the listed applicant for BioSticker System?

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

What is the FDA product code for BioSticker System?

The FDA product code for BioSticker System is DRG.

Other records listing Biointellisense, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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