FDA 510(k) Application Details - K231801

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K231801
Device Name	Sleeve, Limb, Compressible
Applicant	MedHealth Medical Limited 701/101, Bldg 24, Block B, Yuanshan Zone Shangcun, Gongming Shenzhen 518106 CN Other 510(k) Applications for this Company
Contact	Steven Jiang Other 510(k) Applications for this Contact
Regulation Number	870.5800   More FDA Info for this Regulation Number
Classification Product Code	JOW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2023
Decision Date	12/14/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review