FDA 510(k) Application Details - K240646

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K240646
Device Name	Amplifier, Physiological Signal
Applicant	SomnoMed Technologies Inc., doing business as REMware 601 South Harbor Island Boulevard Suite 109 Tampa, FL 33602 US Other 510(k) Applications for this Company
Contact	Arun Ramabadran Other 510(k) Applications for this Contact
Regulation Number	882.1835   More FDA Info for this Regulation Number
Classification Product Code	GWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2024
Decision Date	09/04/2024
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