FDA 510(k) Application Details - K243354

Device Classification Name	More FDA Info for this Device
510(K) Number	K243354
Device Name	Remunity System
Applicant	DEKA Research & Development Corp. 340 Commercial Street Manchester, NH 03101 US Other 510(k) Applications for this Company
Contact	Paul Smolenski Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/2024
Decision Date	11/27/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review