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FDA 510(k)

Epiphany Cardio Server Mobile

K-Number: K181720 · 2018-07-30

ApplicantEpiphany Healthcare, LLC
Decision Date2018-07-30
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Epiphany Cardio Server Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Epiphany Healthcare, LLC. It received FDA 510(k) clearance on 2018-07-30 under 510(k) number K181720. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Epiphany Cardio Server Mobile?

Epiphany Cardio Server Mobile is a medical device that received FDA 510(k) clearance on 2018-07-30. The listed applicant is Epiphany Healthcare, LLC. The 510(k) number is K181720.

When did Epiphany Cardio Server Mobile receive FDA 510(k) clearance?

Epiphany Cardio Server Mobile received FDA 510(k) clearance on 2018-07-30, under 510(k) number K181720.

Who is the listed applicant for Epiphany Cardio Server Mobile?

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

What is the FDA product code for Epiphany Cardio Server Mobile?

The FDA product code for Epiphany Cardio Server Mobile is DQK.

Related Devices (Code: DQK)

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

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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