Altrix Precision Temperature Management System

System, Thermal Regulating

Stryker Medical

The following data is part of a premarket notification filed by Stryker Medical with the FDA for Altrix Precision Temperature Management System.

Pre-market Notification Details

Device IDK180834
510k NumberK180834
Device Name:Altrix Precision Temperature Management System
ClassificationSystem, Thermal Regulating
Applicant Stryker Medical 3800 East Centre Avenue Portage,  MI  49002
ContactBrian Orwat
CorrespondentBrian Orwat
Stryker Medical 3800 East Centre Avenue Portage,  MI  49002
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-30
Decision Date2018-08-10
Summary:summary

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