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FDA 510(k)

STATSTIX

K-Number: K200764 · 2020-10-15

Decision Date2020-10-15
Product CodeMVL
DecisionSubstantially Equivalent

Device Summary

STATSTIX is a medical device manufactured by Centrix Incorporated. It received FDA 510(k) clearance on 2020-10-15 under approval number K200764. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATSTIX?

STATSTIX is a medical device that received FDA 510(k) clearance on 2020-10-15. It is manufactured by Centrix Incorporated. The 510(k) number is K200764.

When was STATSTIX approved by the FDA?

STATSTIX received FDA 510(k) clearance on 2020-10-15, under approval number K200764.

What company makes STATSTIX?

STATSTIX is manufactured by Centrix Incorporated.

What is the FDA product code for STATSTIX?

The FDA product code for STATSTIX is MVL.

Related Devices (Code: MVL)

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.