FDA 510(k) Application Details - K250930

Device Classification Name	More FDA Info for this Device
510(K) Number	K250930
Device Name	twiist system
Applicant	DEKA Research & Development Corp. 340 Commercial Street Manchester, NH 03101 US Other 510(k) Applications for this Company
Contact	William Calhoun 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	03/28/2025
Decision Date	04/02/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review