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510(k) K121669

WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) by Cincinnati Sub-Zero Products, Inc. — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2012
Date Received
June 6, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Thermal Regulating
Device Class
Class II
Regulation Number
870.5900
Review Panel
CV
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Cincinnati Sub-Zero Products, Inc.

  • K123946 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS (January 17, 2013)
  • K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (December 18, 2012)
  • K120081 — NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS (February 17, 2012)
  • K110104 — BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM (February 4, 2011)
  • K101148 — WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS (October 1, 2010)
  • K101589 — BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS (September 20, 2010)
  • K072621 — ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE (December 13, 2007)
  • K070339 — DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES (September 26, 2007)
  • K942599 — WARM AIR WARMING UNIT (January 24, 1995)
  • K942790 — WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) (January 24, 1995)

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