FDA 510(k)

CO Check Pro, CO Screen

K-Number: K171129 · 2018-03-02

Decision Date2018-03-02

Product CodeCCJ

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

CO Check Pro, CO Screen is the device name listed in this FDA 510(k) record. The listed applicant is MD Diagnostics Limited. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K171129. The device is classified under product code CCJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO Check Pro, CO Screen?

CO Check Pro, CO Screen is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is MD Diagnostics Limited. The 510(k) number is K171129.

When did CO Check Pro, CO Screen receive FDA 510(k) clearance?

CO Check Pro, CO Screen received FDA 510(k) clearance on 2018-03-02, under 510(k) number K171129.

Who is the listed applicant for CO Check Pro, CO Screen?

The FDA 510(k) record lists MD Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO Check Pro, CO Screen?

The FDA product code for CO Check Pro, CO Screen is CCJ.

Other records listing MD Diagnostics Limited as applicant

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.