FDA 510(k) Application Details - K121622

Device Classification Name	Tomography, Optical Coherence   More FDA Info for this Device
510(K) Number	K121622
Device Name	Tomography, Optical Coherence
Applicant	NIDEK CO., LTD. 1667 RIDGEWOOD RD WADSWORTH, OH 44281 US Other 510(k) Applications for this Company
Contact	LENA SATTLER 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	06/01/2012
Decision Date	03/14/2013
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