Cleared Traditional

ZOLL RESCUENET EPCR MODEL RESCUENET EPCR

K103473 · ZOLL Medical Corporation · Cardiovascular
May 2011
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K103473 is an FDA 510(k) clearance for the ZOLL RESCUENET EPCR MODEL RESCUENET EPCR, a Display, Cathode-ray Tube, Medical (Class II — Special Controls, product code DXJ), submitted by ZOLL Medical Corporation (Chelmsford, US). The FDA issued a Cleared decision on May 13, 2011, 170 days after receiving the submission on November 24, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2450.

Submission Details

510(k) Number K103473 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2010
Decision Date May 13, 2011
Days to Decision 170 days
Submission Type Traditional
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
ESSENZ Patient Monitor
K212003 · Livanova Deutschland, GmbH · Nov 2021
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