FDA 510(k) Application Details - K191273

Device Classification Name	Cable, Transducer And Electrode, Patient, (Including Connector)   More FDA Info for this Device
510(K) Number	K191273
Device Name	Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant	Vyaire Medical, Inc. 26125 N. Riverwoods Blvd. Mettawa, IL 60630 US Other 510(k) Applications for this Company
Contact	Suzanne Moreno Other 510(k) Applications for this Contact
Regulation Number	870.2900   More FDA Info for this Regulation Number
Classification Product Code	DSA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2019
Decision Date	09/13/2019
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