Babytherm 8004 Babytherm 8010

• • Terminated Z-2295-2016 FDA Class II ·initiated 22 Jun 2016

  Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.

510(k) Number

K971198 ↗

FDA Product Code

FMT

Device Class

Class II

Regulation

21 CFR Part 880.5130

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Drager Incubator 8000 Ic

  Class II

  FDA 510(k) K954204 Active Cleared 25 Apr 1997

• Evita 4

  Class II

  FDA 510(k) K961687 Active Cleared 13 Dec 1996

• Optional Display and Software for Drager Ventilators

  Class II

  FDA 510(k) K950853 Active Cleared 5 Nov 1996

• Babylog 8000 Infant Ventilator

  Class II

  FDA 510(k) K903089 Active Cleared 10 Jun 1991

• Evita

  Class II

  FDA 510(k) K924930 Active Cleared 10 Jan 1994

• Neoflow Option Model Numbers 8413563, 8411900

  Class II

  FDA 510(k) K983219 Active Cleared 7 Dec 1998

See all devices from Drager, Inc. →