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FDA 510(k)

NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS

K-Number: K120081 · 2012-02-17

ApplicantCincinnati Sub-Zero Products, Inc.
Decision Date2012-02-17
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS 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 2012-02-17 under 510(k) number K120081. 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 NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS?

NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS is a medical device that received FDA 510(k) clearance on 2012-02-17. The listed applicant is Cincinnati Sub-Zero Products, Inc.. The 510(k) number is K120081.

When did NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS receive FDA 510(k) clearance?

NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS received FDA 510(k) clearance on 2012-02-17, under 510(k) number K120081.

Who is the listed applicant for NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS?

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 NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS?

The FDA product code for NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS is DWJ.

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

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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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