Cleared Traditional

CV3000 HOLTER ANALYSIS SYSTEM

K131897 · Vales & Hills Biomedical Tech. , Ltd. · Cardiovascular

Nov 2013

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K131897 is an FDA 510(k) clearance for the CV3000 HOLTER ANALYSIS SYSTEM, a Electrocardiograph, Ambulatory, With Analysis Algorithm (Class II — Special Controls, product code MLO), submitted by Vales & Hills Biomedical Tech. , Ltd. (Shanghai, CN). The FDA issued a Cleared decision on November 26, 2013, 154 days after receiving the submission on June 25, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K131897 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 25, 2013
Decision Date	November 26, 2013
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF