FDA 510(k) Application Details - K221782

Device Classification Name	Transducer, Blood-Pressure, Extravascular   More FDA Info for this Device
510(K) Number	K221782
Device Name	Transducer, Blood-Pressure, Extravascular
Applicant	Merit Medical Pte. Ltd. 198 Yishun Avenue 7 Singapore 768926 SG Other 510(k) Applications for this Company
Contact	Pauline Liow Other 510(k) Applications for this Contact
Regulation Number	870.2850   More FDA Info for this Regulation Number
Classification Product Code	DRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2022
Decision Date	03/17/2023
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