FDA 510(k) Application Details - K233584

Device Classification Name	More FDA Info for this Device
510(K) Number	K233584
Device Name	RhythmStar System
Applicant	RhythMedix LLC 5000 Atrium Way STE 1 Mount Laurel, NJ 08054 US Other 510(k) Applications for this Company
Contact	Stan Biletsky Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2023
Decision Date	07/08/2024
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