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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
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