FDA 510(k) Application Details - K213536

Device Classification Name	More FDA Info for this Device
510(K) Number	K213536
Device Name	DEKA ACE Pump System
Applicant	DEKA Research and Development 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	QFG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2021
Decision Date	07/25/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review