Astopad Patient Warming System

System, Thermal Regulating

Stihler Electronic GmbH

The following data is part of a premarket notification filed by Stihler Electronic Gmbh with the FDA for Astopad Patient Warming System.

Pre-market Notification Details

Device IDK202197
510k NumberK202197
Device Name:Astopad Patient Warming System
ClassificationSystem, Thermal Regulating
Applicant Stihler Electronic GmbH Julius-Hoelder-Strasse 36 Stuttgart,  DE 70597
ContactJens- Peter Weege
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-08-05
Decision Date2020-09-04

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