FDA 510(k) Application Details - K213100

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K213100
Device Name	Thermometer, Electronic, Clinical
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 06378 TR Other 510(k) Applications for this Company
Contact	Burcu Firat Other 510(k) Applications for this Contact
Regulation Number	880.2910   More FDA Info for this Regulation Number
Classification Product Code	FLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2021
Decision Date	07/18/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review