FDA 510(k)

Biotres

K-Number: K211709 · 2022-01-19

Decision Date2022-01-19

Product CodeMWJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Biotres is the device name listed in this FDA 510(k) record. The listed applicant is Biotricity. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K211709. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biotres?

Biotres is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Biotricity. The 510(k) number is K211709.

When did Biotres receive FDA 510(k) clearance?

Biotres received FDA 510(k) clearance on 2022-01-19, under 510(k) number K211709.

Who is the listed applicant for Biotres?

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

What is the FDA product code for Biotres?

The FDA product code for Biotres is MWJ.

Other records listing Biotricity 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.

K222017Biotres K201040Bioflux Software II K172311BioFlux Device K162571Bioflux Software

Related Devices (Code: MWJ)

K253562medilogFDSchiller AG K253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)Seers Technology Co., Ltd.K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.K231424HeartBeam AIMIGo(TM) SystemHeartbeam, Inc.K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.K212317Eclipse MINI Model 98900Spacelabs Healthcare, Ltd.

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.