FDA 510(k) Application Details - K241615

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K241615
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	Hony Medical Co., Ltd. No.12,9 Road, Changlong Ind.Zone Taishan 529222 CN Other 510(k) Applications for this Company
Contact	Zhu Huina Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2024
Decision Date	07/03/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review