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FDA 510(k)

Access OV Monitor

K-Number: K240479 · 2024-05-10

ApplicantBeckman Coulter, Inc.
Decision Date2024-05-10
Product CodeLTK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Access OV Monitor is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-05-10 under approval number K240479. The device is classified under product code LTK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access OV Monitor?

Access OV Monitor is a medical device that received FDA 510(k) clearance on 2024-05-10. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K240479.

When was Access OV Monitor approved by the FDA?

Access OV Monitor received FDA 510(k) clearance on 2024-05-10, under approval number K240479.

What company makes Access OV Monitor?

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

What is the FDA product code for Access OV Monitor?

The FDA product code for Access OV Monitor is LTK.

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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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