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FDA 510(k)

KardiaMobile, KardiaStation

K-Number: K182396 · 2019-04-12

ApplicantAliveCor, Inc.
Decision Date2019-04-12
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KardiaMobile, KardiaStation is the device name listed in this FDA 510(k) record. The listed applicant is AliveCor, Inc.. It received FDA 510(k) clearance on 2019-04-12 under 510(k) number K182396. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KardiaMobile, KardiaStation?

KardiaMobile, KardiaStation is a medical device that received FDA 510(k) clearance on 2019-04-12. The listed applicant is AliveCor, Inc.. The 510(k) number is K182396.

When did KardiaMobile, KardiaStation receive FDA 510(k) clearance?

KardiaMobile, KardiaStation received FDA 510(k) clearance on 2019-04-12, under 510(k) number K182396.

Who is the listed applicant for KardiaMobile, KardiaStation?

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

What is the FDA product code for KardiaMobile, KardiaStation?

The FDA product code for KardiaMobile, KardiaStation is DXH. This falls under the Hematology category.

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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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