FDA 510(k) Application Details - K211294

Device Classification Name	Cable, Transducer And Electrode, Patient, (Including Connector)   More FDA Info for this Device
510(K) Number	K211294
Device Name	Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant	Vyaire Medical, Inc. 26125 North Riverwoods Blvd. Mettawa, IL 60045 US Other 510(k) Applications for this Company
Contact	Joshua Davis 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	04/28/2021
Decision Date	08/16/2021
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