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FDA 510(k)

Halo AF Detection System

K-Number: K201208 · 2020-09-23

ApplicantLivmor
Decision Date2020-09-23
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Halo AF Detection System is a medical device manufactured by Livmor. It received FDA 510(k) clearance on 2020-09-23 under approval number K201208. 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 Halo AF Detection System?

Halo AF Detection System is a medical device that received FDA 510(k) clearance on 2020-09-23. It is manufactured by Livmor. The 510(k) number is K201208.

When was Halo AF Detection System approved by the FDA?

Halo AF Detection System received FDA 510(k) clearance on 2020-09-23, under approval number K201208.

What company makes Halo AF Detection System?

Halo AF Detection System is manufactured by Livmor.

What is the FDA product code for Halo AF Detection System?

The FDA product code for Halo AF Detection System is DXH. This falls under the Hematology category.

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Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

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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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