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FDA 510(k)

AFIBALERT ATRIAL FIBRILLATION DETECTOR

K-Number: K052767 · 2006-06-23

ApplicantLechnologies Research, Inc.
Decision Date2006-06-23
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AFIBALERT ATRIAL FIBRILLATION DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Lechnologies Research, Inc.. It received FDA 510(k) clearance on 2006-06-23 under 510(k) number K052767. 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 AFIBALERT ATRIAL FIBRILLATION DETECTOR?

AFIBALERT ATRIAL FIBRILLATION DETECTOR is a medical device that received FDA 510(k) clearance on 2006-06-23. The listed applicant is Lechnologies Research, Inc.. The 510(k) number is K052767.

When did AFIBALERT ATRIAL FIBRILLATION DETECTOR receive FDA 510(k) clearance?

AFIBALERT ATRIAL FIBRILLATION DETECTOR received FDA 510(k) clearance on 2006-06-23, under 510(k) number K052767.

Who is the listed applicant for AFIBALERT ATRIAL FIBRILLATION DETECTOR?

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

What is the FDA product code for AFIBALERT ATRIAL FIBRILLATION DETECTOR?

The FDA product code for AFIBALERT ATRIAL FIBRILLATION DETECTOR is DXH. This falls under the Hematology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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