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FDA 510(k)

Kardia Band System

K-Number: K171816 · 2017-11-16

ApplicantAliveCor, Inc.
Decision Date2017-11-16
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Kardia Band System is the device name listed in this FDA 510(k) record. The listed applicant is AliveCor, Inc.. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K171816. 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 Kardia Band System?

Kardia Band System is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is AliveCor, Inc.. The 510(k) number is K171816.

When did Kardia Band System receive FDA 510(k) clearance?

Kardia Band System received FDA 510(k) clearance on 2017-11-16, under 510(k) number K171816.

Who is the listed applicant for Kardia Band System?

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 Kardia Band System?

The FDA product code for Kardia Band System 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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