FDA 510(k) Application Details - K162067

Device Classification Name	Tonometer, Ac-Powered   More FDA Info for this Device
510(K) Number	K162067
Device Name	Tonometer, Ac-Powered
Applicant	LUNEAU SAS 1 AVE DE MALAGUET PRUNAY-LE-GILLON 28360 FR Other 510(k) Applications for this Company
Contact	ISABELLE DURAND Other 510(k) Applications for this Contact
Regulation Number	886.1930   More FDA Info for this Regulation Number
Classification Product Code	HKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2016
Decision Date	04/24/2017
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