FDA 510(k) Application Details - K232388

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K232388
Device Name	Injector And Syringe, Angiographic
Applicant	Ningbo DIZEGENS Medical Science Co., Ltd. Floor 3&4, Building A4, No. 777, Binhai 4th Road Qianwan New Area. Ningo 315336 CN Other 510(k) Applications for this Company
Contact	Zhang Wenwei Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	DXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2023
Decision Date	11/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review