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FDA 510(k)

Access BR Monitor

K-Number: K240403 · 2024-05-09

ApplicantBeckman Coulter, Inc.
Decision Date2024-05-09
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Access BR Monitor is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-05-09 under approval number K240403. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access BR Monitor?

Access BR Monitor is a medical device that received FDA 510(k) clearance on 2024-05-09. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K240403.

When was Access BR Monitor approved by the FDA?

Access BR Monitor received FDA 510(k) clearance on 2024-05-09, under approval number K240403.

What company makes Access BR Monitor?

Access BR Monitor is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access BR Monitor?

The FDA product code for Access BR Monitor is MOI.

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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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