FDA 510(k) Application Details - K243837

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K243837
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	iOrbit Digital Technologies Private Limited 4th floor, Nagamma Devi Complex, Site No. 22, Survey No. 81/2E, Bannerghatta Main Road Bangalore 560076 IN Other 510(k) Applications for this Company
Contact	Sandeep Zende 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	12/13/2024
Decision Date	05/16/2025
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