FDA 510(k) Application Details - K250091

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K250091
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Korot Co. Ltd. 1-102, 330, Yeongok-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si Chungcheongnam-do Cheonan 31026 KR Other 510(k) Applications for this Company
Contact	Muyeol Lee Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/14/2025
Decision Date	03/14/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	Y
Expedited Review