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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 the device name listed in this FDA 510(k) record. The listed applicant is Check-Points Health B.V.. It received FDA 510(k) clearance on 2019-08-29 under 510(k) 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. The listed applicant is Check-Points Health B.V.. The 510(k) number is K190613.

When did BD MAX Check-Points CPO receive FDA 510(k) clearance?

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

Who is the listed applicant for BD MAX Check-Points CPO?

The FDA 510(k) record lists Check-Points Health B.V. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: POC)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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