Cleared Traditional

Diagnostic Station DS20

K152043 · Schiller AG · Cardiovascular
May 2016
Decision
288d
Days
Class 2
Risk

About This 510(k) Submission

K152043 is an FDA 510(k) clearance for the Diagnostic Station DS20, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Schiller AG (Baar, CH). The FDA issued a Cleared decision on May 6, 2016, 288 days after receiving the submission on July 23, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K152043 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2015
Decision Date May 06, 2016
Days to Decision 288 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