FDA 510(k)

WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)

K-Number: K121669 · 2012-07-03

ApplicantCincinnati Sub-Zero Products, Inc.

Decision Date2012-07-03

Product CodeDWJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) is the device name listed in this FDA 510(k) record. The listed applicant is Cincinnati Sub-Zero Products, Inc.. It received FDA 510(k) clearance on 2012-07-03 under 510(k) number K121669. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)?

WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) is a medical device that received FDA 510(k) clearance on 2012-07-03. The listed applicant is Cincinnati Sub-Zero Products, Inc.. The 510(k) number is K121669.

When did WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) receive FDA 510(k) clearance?

WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) received FDA 510(k) clearance on 2012-07-03, under 510(k) number K121669.

Who is the listed applicant for WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)?

The FDA 510(k) record lists Cincinnati Sub-Zero Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)?

The FDA product code for WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) is DWJ.

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Other records listing Cincinnati Sub-Zero Products, Inc. as applicant

K123946WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS K122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM K120081NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS K110104BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM K101148WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS K101589BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS

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Related Devices (Code: DWJ)

K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC Life K260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbH K260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.