FDA 510(k) Application Details - K240700

Device Classification Name	Standard Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K240700
Device Name	Standard Polysomnograph With Electroencephalograph
Applicant	Somnomedics GMBH Am Sonnenstuhl 63 Randersacker 97236 DE Other 510(k) Applications for this Company
Contact	Cherita James Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2024
Decision Date	12/08/2024
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