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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 K240223
Device Name FMT Disposable and Autoclavable Temperature Probes
Applicant
Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi
Ivedik O.S.B. Agaç Isleri Sanayi Sitesi 1354. Cad. 1358.
Sok. No: 9
Yenimahalle-Ankara,  TR 06378
Applicant Contact Metehan Firat
Correspondent
Arazy Group Consultants, Inc.
3422 Leonardo Lane
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/26/2024
Decision Date 10/25/2024
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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