FDA 510(k)

Digistat Smart Central

K-Number: K180430 · 2018-11-23

Decision Date2018-11-23

Product CodeMSX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Digistat Smart Central is a medical device manufactured by Ascom Ums Srl Unipersonale. It received FDA 510(k) clearance on 2018-11-23 under approval number K180430. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digistat Smart Central?

Digistat Smart Central is a medical device that received FDA 510(k) clearance on 2018-11-23. It is manufactured by Ascom Ums Srl Unipersonale. The 510(k) number is K180430.

When was Digistat Smart Central approved by the FDA?

Digistat Smart Central received FDA 510(k) clearance on 2018-11-23, under approval number K180430.

What company makes Digistat Smart Central?

Digistat Smart Central is manufactured by Ascom Ums Srl Unipersonale.

What is the FDA product code for Digistat Smart Central?

The FDA product code for Digistat Smart Central is MSX.

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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.