STERIS Patient Warming System

System, Thermal Regulating

STERIS Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Steris Patient Warming System.

Pre-market Notification Details

Device IDK200446
510k NumberK200446
Device Name:STERIS Patient Warming System
ClassificationSystem, Thermal Regulating
Applicant STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
ContactGregory Land
CorrespondentGregory Land
STERIS Corporation 5960 Heisley Road Mentor,  OH  44060
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-24
Decision Date2020-06-13

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