C3 Wave System

• • Terminated Z-0222-2020 FDA Class II ·initiated 1 Oct 2018

  When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement.

510(k) Number

K170934 ↗

FDA Product Code

LJS

FDA applicant

Medical Components, Inc (Dba Medcomp_

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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