FDA 510(k) Application Details - K181534

Device Classification Name	Tomography, Optical Coherence   More FDA Info for this Device
510(K) Number	K181534
Device Name	Tomography, Optical Coherence
Applicant	Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 US Other 510(k) Applications for this Company
Contact	Mandy Ambrecht Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	OBO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2018
Decision Date	02/15/2019
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