FDA 510(k) Application Details - K250153

Device Classification Name	Transducer, Tremor   More FDA Info for this Device
510(K) Number	K250153
Device Name	Transducer, Tremor
Applicant	Neuhealth Digital Ltd. 10 Fitzroy Square London W1T 5HP GB Other 510(k) Applications for this Company
Contact	Giovanni Maggi Other 510(k) Applications for this Contact
Regulation Number	882.1950   More FDA Info for this Regulation Number
Classification Product Code	GYD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2025
Decision Date	04/25/2025
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	Y
Expedited Review