FDA 510(k) Application Details - K230571

Device Classification Name	Cable, Transducer And Electrode, Patient, (Including Connector)   More FDA Info for this Device
510(K) Number	K230571
Device Name	Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant	Baylis Medical Technologies Inc. 2645 Matheson Blvd. East Mississauga L4W 5S4 CA Other 510(k) Applications for this Company
Contact	Gallone Stephanie 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	03/01/2023
Decision Date	05/30/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review