Cleared Traditional

Cardiac Monitor 1500

K191697 · Zynex Medical, Inc. · Cardiovascular
Feb 2020
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K191697 is an FDA 510(k) clearance for the Cardiac Monitor 1500, a Plethysmograph, Impedance (Class II — Special Controls, product code DSB), submitted by Zynex Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on February 21, 2020, 241 days after receiving the submission on June 25, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number K191697 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2019
Decision Date February 21, 2020
Days to Decision 241 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSB — Plethysmograph, Impedance
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2770