FDA 510(k) Application Details - K230386

Device Classification Name	More FDA Info for this Device
510(K) Number	K230386
Device Name	SpassageQ
Applicant	Spass Inc. Unit 905, 396 World Cup buk-ro, Mapo-gu Seoul 03925 KR Other 510(k) Applications for this Company
Contact	Yonghwan Kim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2023
Decision Date	06/15/2023
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