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FDA 510(k)

Epicardia Anywhere

K-Number: K173170 · 2018-01-10

ApplicantMedicomp, Inc.
Decision Date2018-01-10
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Epicardia Anywhere is a medical device manufactured by Medicomp, Inc.. It received FDA 510(k) clearance on 2018-01-10 under approval number K173170. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Epicardia Anywhere?

Epicardia Anywhere is a medical device that received FDA 510(k) clearance on 2018-01-10. It is manufactured by Medicomp, Inc.. The 510(k) number is K173170.

When was Epicardia Anywhere approved by the FDA?

Epicardia Anywhere received FDA 510(k) clearance on 2018-01-10, under approval number K173170.

What company makes Epicardia Anywhere?

Epicardia Anywhere is manufactured by Medicomp, Inc..

What is the FDA product code for Epicardia Anywhere?

The FDA product code for Epicardia Anywhere is DSI.

Other Devices by Medicomp, Inc.

K161916TelePatch Cardiac Monitor

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Official Source

View on FDA Database →

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

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