Cleared Traditional

CER-S

K193177 · Cardiocalm · Cardiovascular

Aug 2020

Decision

282d

Days

Class 2

Risk

About This 510(k) Submission

K193177 is an FDA 510(k) clearance for the CER-S, a Electrocardiograph, Ambulatory, With Analysis Algorithm (Class II — Special Controls, product code MLO), submitted by Cardiocalm (Montichiari, IT). The FDA issued a Cleared decision on August 26, 2020, 282 days after receiving the submission on November 18, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K193177 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 2019
Decision Date	August 26, 2020
Days to Decision	282 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF