Cleared Special

ESSENZ Patient Monitor

K212003 · Livanova Deutschland, GmbH · Cardiovascular
Nov 2021
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K212003 is an FDA 510(k) clearance for the ESSENZ Patient Monitor, a Display, Cathode-ray Tube, Medical (Class II — Special Controls, product code DXJ), submitted by Livanova Deutschland, GmbH (Munich, DE). The FDA issued a Cleared decision on November 10, 2021, 135 days after receiving the submission on June 28, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number K212003 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2021
Decision Date November 10, 2021
Days to Decision 135 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXJ — Display, Cathode-ray Tube, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2450

Similar Devices — DXJ Display, Cathode-ray Tube, Medical

All 77
Philips IntelliVue GuardianSoftware (Rev. E.0X)
K212208 · Philips Medizin Systeme Boeblingen GmbH · Sep 2021
Essence 55SP Large Monitor System
K201162 · Shenyang Torch-Bigtide Digital Technology Co., Ltd. · Aug 2020
Vios Central Station Monitor Software, Vios Central Server Software
K173107 · Vios Medical, Inc. · Jul 2018
Philips IntelliVue GuardianSoftware
K180534 · Philips Medizin Systeme Boeblingen GmbH · Jul 2018
Nexxis OR
K173381 · Barco N.V. · Feb 2018
Essence 55S Large Monitor System
K172969 · Shenyang Torch-Bigtide Digital Technology Co., Ltd. · Jan 2018