FDA 510(k) Application Details - K200697

Device Classification Name	Device, Surgical, Cryogenic   More FDA Info for this Device
510(K) Number	K200697
Device Name	Device, Surgical, Cryogenic
Applicant	AtriCure Inc. 7555 Innovation Way Mason, OH 45040 US Other 510(k) Applications for this Company
Contact	Melissa Smallwood Other 510(k) Applications for this Contact
Regulation Number	882.4250   More FDA Info for this Regulation Number
Classification Product Code	GXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/17/2020
Decision Date	12/23/2020
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