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FDA 510(k)

Altrix Precision Temperature Management System

K-Number: K152266 · 2016-12-02

ApplicantStryker Medical
Decision Date2016-12-02
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Altrix Precision Temperature Management System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Medical. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K152266. 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 Altrix Precision Temperature Management System?

Altrix Precision Temperature Management System is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is Stryker Medical. The 510(k) number is K152266.

When did Altrix Precision Temperature Management System receive FDA 510(k) clearance?

Altrix Precision Temperature Management System received FDA 510(k) clearance on 2016-12-02, under 510(k) number K152266.

Who is the listed applicant for Altrix Precision Temperature Management System?

The FDA 510(k) record lists Stryker Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Altrix Precision Temperature Management System?

The FDA product code for Altrix Precision Temperature Management System is DWJ.

Other records listing Stryker Medical 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.

K222818Xpedition ™ Powered Stair Chair (625700000000)K180834Altrix Precision Temperature Management SystemK171149Altrix Temperature Management Wraps

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.

K260278ThermAffyx(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.K242964Celsi WarmerHadleigh Health TechnologiesK243942Arctic Sun Stat Temperature Management SystemMedivance, 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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