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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K171182
Device Name ri-former Predictive Thermometer
Applicant
Rudolf Riester GmbH
P.O.B. 35, Bruckstraße 31
Junginge,  DE DE-72417
Applicant Contact Artur Pfister
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
7th Floor, Jingui Business Building
No.982 Congyun Rd, Baiyun District
Guangzhou,  CN 510420
Correspondent Contact Mike Gu
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/24/2017
Decision Date 10/04/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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