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FDA 510(k)

WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS

K-Number: K101148 · 2010-10-01

ApplicantCincinnati Sub-Zero Products, Inc.
Decision Date2010-10-01
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WARM AIR MODEL 135 HYPERTHERMIA SYSTEM 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 2010-10-01 under 510(k) number K101148. 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 WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS?

WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS is a medical device that received FDA 510(k) clearance on 2010-10-01. The listed applicant is Cincinnati Sub-Zero Products, Inc.. The 510(k) number is K101148.

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

WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS received FDA 510(k) clearance on 2010-10-01, under 510(k) number K101148.

Who is the listed applicant for WARM AIR MODEL 135 HYPERTHERMIA SYSTEM 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 WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS?

The FDA product code for WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS is DWJ.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123946WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETSK122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMK121669WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)K120081NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADSK110104BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEMK101589BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS

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Related Devices (Code: DWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot 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.

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