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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 the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 2018-01-10 under 510(k) 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. The listed applicant is Medicomp, Inc.. The 510(k) number is K173170.

When did Epicardia Anywhere receive FDA 510(k) clearance?

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

Who is the listed applicant for Epicardia Anywhere?

The FDA 510(k) record lists Medicomp, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Epicardia Anywhere?

The FDA product code for Epicardia Anywhere is DSI.

Other records listing Medicomp, Inc. 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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Related Devices (Code: DSI)

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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