FDA 510(k) Application Details - K240707

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K240707
Device Name	Scaler, Ultrasonic
Applicant	Shenzhen Micro Electric Intelligence Co., Ltd. 301, Building A5, No. 13 Baonan Road, Longgang Community Longgang District Shenzhen 518100 CN Other 510(k) Applications for this Company
Contact	Fengmeng Han Other 510(k) Applications for this Contact
Regulation Number	872.4850   More FDA Info for this Regulation Number
Classification Product Code	ELC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2024
Decision Date	07/02/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review