FDA 510(k) Application Details - K250259

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K250259
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	The ScottCare Corporation 4791 West 150th Street Cleveland, OH 44135 US Other 510(k) Applications for this Company
Contact	Matthew Tarler Other 510(k) Applications for this Contact
Regulation Number	870.2910   More FDA Info for this Regulation Number
Classification Product Code	DRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/2025
Decision Date	06/04/2025
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