FDA 510(k) Application Details - K232241

Device Classification Name	System, Ablation, Microwave And Accessories   More FDA Info for this Device
510(K) Number	K232241
Device Name	System, Ablation, Microwave And Accessories
Applicant	Betters(Suzhou) Medical Co., Ltd Room 101, 201, 501, Building 7,52 Yin gang Road Taicang Port Economic and Technological Development Zone Suzhou 215412 CN Other 510(k) Applications for this Company
Contact	Lei Liu Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	NEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2023
Decision Date	11/13/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review