FDA 510(k) Application Details - K212696

Device Classification Name	Apparatus, Suction, Patient Care   More FDA Info for this Device
510(K) Number	K212696
Device Name	Apparatus, Suction, Patient Care
Applicant	Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 US Other 510(k) Applications for this Company
Contact	Jennifer Webb Other 510(k) Applications for this Contact
Regulation Number	870.5050   More FDA Info for this Regulation Number
Classification Product Code	DWM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2021
Decision Date	03/03/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review