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 a medical device manufactured by AliveCor, Inc.. It received FDA 510(k) clearance on 2017-11-16 under approval 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. It is manufactured by AliveCor, Inc.. The 510(k) number is K171816.
When was Kardia Band System approved by the FDA?
Kardia Band System received FDA 510(k) clearance on 2017-11-16, under approval number K171816.
What company makes Kardia Band System?
Kardia Band System is manufactured by AliveCor, Inc..
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.
Related Clinical Trials
Other Devices by AliveCor, Inc.
Related Devices (Code: DXH)
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.