FDA 510(k) Application Details - K181444

Device Classification Name	More FDA Info for this Device
510(K) Number	K181444
Device Name	CLARUS
Applicant	Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 US Other 510(k) Applications for this Company
Contact	Saurabh Jamkhindikar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QER Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2018
Decision Date	01/10/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review