Cleared Traditional

CARDIOSPY ECG HOLTER SYSTEMS

K140847 · Labtech Kft. · Cardiovascular

Dec 2014

Decision

246d

Days

Class 2

Risk

About This 510(k) Submission

K140847 is an FDA 510(k) clearance for the CARDIOSPY ECG HOLTER SYSTEMS, a Electrocardiograph, Ambulatory, With Analysis Algorithm (Class II — Special Controls, product code MLO), submitted by Labtech Kft. (Debrecen, HU). The FDA issued a Cleared decision on December 5, 2014, 246 days after receiving the submission on April 3, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K140847 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 2014
Decision Date	December 05, 2014
Days to Decision	246 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF