FDA 510(k) Application Details - K240223

Device Classification Name	Thermometer, Electronic, Clinical   More FDA Info for this Device
510(K) Number	K240223
Device Name	Thermometer, Electronic, Clinical
Applicant	Metko Medikal ve Tibbi Cihazlar Dis Ticaret Limited Sirketi Ivedik O.S.B. Agaτ Isleri Sanayi Sitesi 1354. Cad. 1358. Sok. No: 9 Yenimahalle-Ankara 06378 TR Other 510(k) Applications for this Company
Contact	Metehan 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	01/26/2024
Decision Date	10/25/2024
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