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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K213100
Device Name FMT Reusable Temperature Probes
Applicant
Metko Medikal ve Ttbbi Cihazlar D1s Ticaret Ltd. Sti
Ivedik O.S.B. Agac Isleri Sanayi Sitesi 1354, Cad. 1358. Sok
No:9
Yenimahalle - Ankara,  TR 06378
Applicant Contact Burcu Firat
Correspondent
Arazy Group Consultants Inc.
3422 Leonardo Lane
New Smyrna Beach,  FL  32168
Correspondent Contact Ray Kelly
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/24/2021
Decision Date 07/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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