FDA 510(k) Application Details - K240877

Device Classification Name	Neurosurgical Laser With Mr Thermography   More FDA Info for this Device
510(K) Number	K240877
Device Name	Neurosurgical Laser With Mr Thermography
Applicant	Monteris Medical 131 Cheshire Lane Suite 100 Minnetonka, MN 55305 US Other 510(k) Applications for this Company
Contact	David H. Mueller Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2024
Decision Date	06/04/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review