Uni-Vent Model 73X

• • Terminated Z-0870-2012 FDA Unclassified (pre-2012) ·initiated 4 Nov 2011

  A piece of internal tubing in the 73X portable ventilator is of incorrect specifications for the device.

510(k) Number

K051476 ↗

FDA Product Code

BTL

Device Class

Class II

Regulation

21 CFR Part 868.5925

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. →