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FDA 510(k)

CRITICOOL

K-Number: K083662 · 2009-03-26

ApplicantMtre Advanced Technology , Ltd.
Decision Date2009-03-26
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRITICOOL is the device name listed in this FDA 510(k) record. The listed applicant is Mtre Advanced Technology , Ltd.. It received FDA 510(k) clearance on 2009-03-26 under 510(k) number K083662. 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 CRITICOOL?

CRITICOOL is a medical device that received FDA 510(k) clearance on 2009-03-26. The listed applicant is Mtre Advanced Technology , Ltd.. The 510(k) number is K083662.

When did CRITICOOL receive FDA 510(k) clearance?

CRITICOOL received FDA 510(k) clearance on 2009-03-26, under 510(k) number K083662.

Who is the listed applicant for CRITICOOL?

The FDA 510(k) record lists Mtre Advanced Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRITICOOL?

The FDA product code for CRITICOOL is DWJ.

Related Clinical Trials

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.

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Other records listing Mtre Advanced Technology , Ltd. 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.

K102112CRITICOOL PROK024128ALLON 2001 VERSION 5K003349ALLON 2001 MODIFIEDK001546ALLON 2001K992386ALLON 2000

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

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

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