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FDA 510(k)

Demetra Analytics Toolkit

K-Number: K201408 · 2021-02-18

ApplicantBarco N.V.
Decision Date2021-02-18
Product CodePSN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Demetra Analytics Toolkit is the device name listed in this FDA 510(k) record. The listed applicant is Barco N.V.. It received FDA 510(k) clearance on 2021-02-18 under 510(k) number K201408. The device is classified under product code PSN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Demetra Analytics Toolkit?

Demetra Analytics Toolkit is a medical device that received FDA 510(k) clearance on 2021-02-18. The listed applicant is Barco N.V.. The 510(k) number is K201408.

When did Demetra Analytics Toolkit receive FDA 510(k) clearance?

Demetra Analytics Toolkit received FDA 510(k) clearance on 2021-02-18, under 510(k) number K201408.

Who is the listed applicant for Demetra Analytics Toolkit?

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

What is the FDA product code for Demetra Analytics Toolkit?

The FDA product code for Demetra Analytics Toolkit is PSN.

Other records listing Barco N.V. 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.

K243307LCD Monitor (MDEC-2523)K242008Coronis OneLookK233693Nio Color 8MP (MDNC-8132)K230520Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)K213957Demetra Dermatoscope BDEM-01K203364MDPC-8127

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Related Devices (Code: PSN)

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.

K230448DeepX DermoSight DermatoscopeDeepx Health, LLCK213957Demetra Dermatoscope BDEM-01Barco N.V.K192829Demetra BDEM-01 DermatoscopeBarco N.V.K180162VivaScope SystemCaliber Imaging & Diagnostics, Inc.

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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