FDA 510(k) Application Details - K243520

Device Classification Name	More FDA Info for this Device
510(K) Number	K243520
Device Name	Bullsai Confirm
Applicant	Turing Medical Technologies, Inc. 393 N Euclid Ave Suite 310 Saint Louis, MO 63108 US Other 510(k) Applications for this Company
Contact	Christa Nova Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2024
Decision Date	03/28/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review