FDA 510(k) Application Details - K193662

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K193662
Device Name	Sleeve, Limb, Compressible
Applicant	Eezcare Medical Corp NO. 3-1, Minquan St New Taipei City 236, Taipei 23679 TW Other 510(k) Applications for this Company
Contact	Michelle C Mitchell 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	12/31/2019
Decision Date	02/11/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review