FDA 510(k) Application Details - K241890

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K241890
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	Philips Medizin Systeme B÷blingen GmbH Hewlett-Packard Strasse 2 B÷blingen 71034 DE Other 510(k) Applications for this Company
Contact	Cathy Hong Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MLO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2024
Decision Date	03/21/2025
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