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510(k) K101589

BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS by Cincinnati Sub-Zero Products, Inc. — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2010
Date Received
June 7, 2010
Clearance Type
Traditional
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)
  • K121669 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) (July 3, 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)
  • 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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  • K232627 — HotDog Warming Mattress + Return Electrode (April 18, 2024)
  • K232502 — Cocoon Convective Warming System, Model CWS7000 (February 21, 2024)
  • K231211 — Medline ComfortTemp Patient Warming System (December 1, 2023)
  • K232638 — FilteredFlo Warming Blankets (October 24, 2023)
  • K232844 — The IQoolTM System (October 4, 2023)
  • K232508 — Barrier EasyWarm Active Self-Warming Blanket (September 15, 2023)
  • K231596 — IOB Temperature Management System (June 30, 2023)