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FDA 510(k)

KardiaMobile 6L

K-Number: K210753 · 2021-06-30

ApplicantAliveCor, Inc.
Decision Date2021-06-30
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KardiaMobile 6L is the device name listed in this FDA 510(k) record. The listed applicant is AliveCor, Inc.. It received FDA 510(k) clearance on 2021-06-30 under 510(k) number K210753. 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 6L?

KardiaMobile 6L is a medical device that received FDA 510(k) clearance on 2021-06-30. The listed applicant is AliveCor, Inc.. The 510(k) number is K210753.

When did KardiaMobile 6L receive FDA 510(k) clearance?

KardiaMobile 6L received FDA 510(k) clearance on 2021-06-30, under 510(k) number K210753.

Who is the listed applicant for KardiaMobile 6L?

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 6L?

The FDA product code for KardiaMobile 6L is DXH. This falls under the Hematology category.

Other records listing AliveCor, 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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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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