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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 a medical device manufactured by Epiphany Healthcare, LLC. It received FDA 510(k) clearance on 2018-07-30 under approval 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. It is manufactured by Epiphany Healthcare, LLC. The 510(k) number is K181720.

When was Epiphany Cardio Server Mobile approved by the FDA?

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

What company makes Epiphany Cardio Server Mobile?

Epiphany Cardio Server Mobile is manufactured by Epiphany Healthcare, LLC.

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

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

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Official Source

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