Warm Air Model 135 Hyperthermia System and Blankets

• • Terminated Z-3119-2011 FDA Unclassified (pre-2012) ·initiated 20 Jul 2011

  Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling regulations.

• • Terminated Z-2888-2011 FDA Unclassified (pre-2012) ·initiated 1 Jun 2011

  Due to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket.

510(k) Number

K101148 ↗

FDA Product Code

DWJ

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Hemotherm Model 400CE Cooler/Heater System

  Class II

  FDA 510(k) K122813 Active Cleared 18 Dec 2012

• Norm-O-Temp Hyperthermia System Incliding Blankets/Pads

  Class II

  FDA 510(k) K120081 Active Cleared 17 Feb 2012

• Warmair Model 135 Hyperthermia System Including Filteredflo Blankets

  Class II

  FDA 510(k) K123946 Active Cleared 17 Jan 2013

• Disposable Temperature Probes/Sensors and Instrument Cables

  Class II

  FDA 510(k) K070339 Active Cleared 26 Sep 2007

• Warm Air Warming Unit

  Class II

  FDA 510(k) K942599 Active Cleared 24 Jan 1995

• Warm Air Hypertheermia System (Models #130 and #133)

  Class II

  FDA 510(k) K942790 Active Cleared 24 Jan 1995

See all devices from Cincinnati Sub-Zero Products, Inc. →