FDA-Device2022-04-20Class II
CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
Graphic Controls Acquisition Corporation
Hazard
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.
Sold states
US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT.
Affected count
N/A
Manufactured in
400 Exchange St, N/A, Buffalo, NY, United States
Products
CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0940-2022Don't want to check this manually?
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