FDA 510(k) Application Details - K190887

Device Classification Name	Neurological Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K190887
Device Name	Neurological Stereotaxic Instrument
Applicant	Elekta Instrument AB Kungstensgatan 18 Stockholm 10393 SE Other 510(k) Applications for this Company
Contact	Helena Skar Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	HAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2019
Decision Date	08/01/2019
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