FDA 510(k) Application Details - K243545

Device Classification Name	Cable, Transducer And Electrode, Patient, (Including Connector)   More FDA Info for this Device
510(K) Number	K243545
Device Name	Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant	Philips Medizin Systeme B÷blingen GmbH Hewlett-Packard-Str. 2 None B÷blingen 71034 DE Other 510(k) Applications for this Company
Contact	Namita Nandurkar 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	11/15/2024
Decision Date	01/17/2025
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