General Anesthesia System

• • Terminated Z-0407-2013 FDA Class II ·initiated 17 Aug 2012 ·via K944949, on the same 510(k)

  There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K944949 ↗

FDA Product Code

BTK

Device Class

Class I

Regulation

21 CFR Part 868.5560

Advisory Committee

Anesthesiology

FDA Decision

SESK Substantially Equivalent — Kit

• 1.1, 1.2, 1.3 Temperature Probes

  Class II

  FDA 510(k) K912650 Active Cleared 16 Aug 1991

• Pediatric Anesthesia Circuit

  Class I

  FDA 510(k) K801111 Active Cleared 23 May 1980

• Blood Pressure Cuffs

  Class II

  FDA 510(k) K912638 Active Cleared 25 Jul 1991

• Downs Cap Flow Generator

  Class II

  FDA 510(k) K811393 Active Cleared 9 Jun 1981

• Circuit Anes. Breathing & Components

  Class I

  FDA 510(k) K862003 Active Cleared 7 Jul 1986

• Enflow Iv Fluid Warmer

  Class II

  FDA 510(k) K112902 Active Cleared 14 Mar 2012

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