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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K180834
Device Name Altrix Precision Temperature Management System
Applicant
Stryker Medical
3800 E. Centre Ave.
Portage,  MI  49002
Applicant Contact Brian Orwat
Correspondent
Stryker Medical
3800 E. Centre Ave.
Portage,  MI  49002
Correspondent Contact Brian Orwat
Regulation Number870.5900
Classification Product Code
DWJ  
Subsequent Product Code
FLL  
Date Received03/30/2018
Decision Date 08/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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