Cleared Traditional

SmartCardia 7L Platform

K231276 · Smartcardia SA · Cardiovascular

Aug 2023

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K231276 is an FDA 510(k) clearance for the SmartCardia 7L Platform, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Smartcardia SA (Lausanne, CH). The FDA issued a Cleared decision on August 30, 2023, 120 days after receiving the submission on May 2, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K231276 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2023
Decision Date	August 30, 2023
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF