FDA 510(k) Application Details - K180895

Device Classification Name	Grid, Amsler   More FDA Info for this Device
510(K) Number	K180895
Device Name	Grid, Amsler
Applicant	Oculocare Medical AG Verena Conzett Strasse 9 Zurich ZH 8004 CH Other 510(k) Applications for this Company
Contact	Lucas Bachmann Other 510(k) Applications for this Contact
Regulation Number	886.1330   More FDA Info for this Regulation Number
Classification Product Code	HOQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2018
Decision Date	06/27/2018
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