510(k) K942790

WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) by Cincinnati Sub-Zero Products, Inc. — Product Code DWJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 24, 1995
Date Received: June 13, 1994
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)
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)

Other clearances for product code DWJ

K251974 — Arctic Sun Temperature Management System (Model 5000) (October 24, 2025)
K242964 — Celsi Warmer (June 20, 2025)
K243942 — Arctic Sun Stat Temperature Management System (April 30, 2025)
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)