Cleared Traditional

CARDIOVIT FT-1

K170182 · Schiller AG · Cardiovascular
Jul 2017
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K170182 is an FDA 510(k) clearance for the CARDIOVIT FT-1, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Schiller AG (Baar, CH). The FDA issued a Cleared decision on July 19, 2017, 177 days after receiving the submission on January 23, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K170182 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2017
Decision Date July 19, 2017
Days to Decision 177 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340