Uni-Vent 731 Series Model Emv+ Portable Critical Care Ventilator

• • Terminated Z-0812-2018 FDA Class II ·initiated 30 Jun 2017

  A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.

• • Terminated Z-2152-2012 FDA Class III ·initiated 19 Mar 2012

  Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB.

510(k) Number

K103318 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Impact, Models 306/307

  Class II

  FDA 510(k) K820338 Active Cleared 2 Mar 1982

• Impact Model E-12

  Class II

  FDA 510(k) K820330 Active Cleared 23 Feb 1982

• Impact Model 308

  Class II

  FDA 510(k) K841538 Active Cleared 11 Jun 1984

• Impact Model 753

  Class II

  FDA 510(k) K931473 Active Cleared 30 Dec 1994

• Impact 901 Series Port-a-Wall

  Class I

  FDA 510(k) K850671 Active Cleared 11 Mar 1985

• Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00

  Class II

  FDA 510(k) K022062 Active Cleared 6 May 2003

See all devices from Impact Instrumentation, Inc. →