Alice

• • Terminated Z-1090-2008 FDA Unclassified (pre-2012) ·initiated 15 Oct 2007 ·on shared 510(k) K922106

  Foreign material: Glass fragments may present in the plastic bag material used to ship components.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K922106 ↗

FDA Product Code

OLV

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Healthdyne Impluse Ventilator

  Class II

  FDA 510(k) K853300 Active Cleared 15 Aug 1985

• Oxygen Concentrator, Model Bx-5000

  Class II

  FDA 510(k) K854374 Active Cleared 3 Jan 1986

• Healthdyne Event Recorder System

  Class II

  FDA 510(k) K860254 Active Cleared 30 Jan 1986

• Healthdyne Rate Meter

  Class II

  FDA 510(k) K874814 Active Cleared 11 Feb 1988

• Oxygen/Pulse Monitor

  Class II

  FDA 510(k) K875031 Active Cleared 12 Feb 1988

• Healthdyne's Apnea/Heart Monitor, Model 900S

  Class II

  FDA 510(k) K892006 Active Cleared 23 May 1989

See all devices from Healthdyne, Inc. →