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FDA 510(k)

BresoDX1

K-Number: K220012 · 2022-12-21

ApplicantBresotec, Inc.
Decision Date2022-12-21
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BresoDX1 is a medical device manufactured by Bresotec, Inc.. It received FDA 510(k) clearance on 2022-12-21 under approval number K220012. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BresoDX1?

BresoDX1 is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Bresotec, Inc.. The 510(k) number is K220012.

When was BresoDX1 approved by the FDA?

BresoDX1 received FDA 510(k) clearance on 2022-12-21, under approval number K220012.

What company makes BresoDX1?

BresoDX1 is manufactured by Bresotec, Inc..

What is the FDA product code for BresoDX1?

The FDA product code for BresoDX1 is MNR.

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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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