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FDA 510(k)

BD MAX Check-Points CPO

K-Number: K190613 · 2019-08-29

ApplicantCheck-Points Health B.V.
Decision Date2019-08-29
Product CodePOC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD MAX Check-Points CPO is a medical device manufactured by Check-Points Health B.V.. It received FDA 510(k) clearance on 2019-08-29 under approval number K190613. The device is classified under product code POC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD MAX Check-Points CPO?

BD MAX Check-Points CPO is a medical device that received FDA 510(k) clearance on 2019-08-29. It is manufactured by Check-Points Health B.V.. The 510(k) number is K190613.

When was BD MAX Check-Points CPO approved by the FDA?

BD MAX Check-Points CPO received FDA 510(k) clearance on 2019-08-29, under approval number K190613.

What company makes BD MAX Check-Points CPO?

BD MAX Check-Points CPO is manufactured by Check-Points Health B.V..

What is the FDA product code for BD MAX Check-Points CPO?

The FDA product code for BD MAX Check-Points CPO is POC.

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Official Source

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