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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 the device name listed in this FDA 510(k) record. The listed applicant is Bresotec, Inc.. It received FDA 510(k) clearance on 2022-12-21 under 510(k) 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. The listed applicant is Bresotec, Inc.. The 510(k) number is K220012.

When did BresoDX1 receive FDA 510(k) clearance?

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

Who is the listed applicant for BresoDX1?

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

What is the FDA product code for BresoDX1?

The FDA product code for BresoDX1 is MNR.

Related Devices (Code: MNR)

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

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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