Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CRITICOOL PRO

K-Number: K102112 · 2010-11-18

ApplicantMtre Advanced Technology , Ltd.
Decision Date2010-11-18
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRITICOOL PRO 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 2010-11-18 under 510(k) number K102112. 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 PRO?

CRITICOOL PRO is a medical device that received FDA 510(k) clearance on 2010-11-18. The listed applicant is Mtre Advanced Technology , Ltd.. The 510(k) number is K102112.

When did CRITICOOL PRO receive FDA 510(k) clearance?

CRITICOOL PRO received FDA 510(k) clearance on 2010-11-18, under 510(k) number K102112.

Who is the listed applicant for CRITICOOL PRO?

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 PRO?

The FDA product code for CRITICOOL PRO 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K083662CRITICOOLK024128ALLON 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

View on FDA Database →

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

↑