FDA 510(k) Application Details - K181260

Device Classification Name	Tonometer, Ac-Powered   More FDA Info for this Device
510(K) Number	K181260
Device Name	Tonometer, Ac-Powered
Applicant	Medimaging Integrated Solution Inc. (MiiS) 1F, No.7, R&D Rd. II Hsinchu Science Park Hsinchu 30076 CN Other 510(k) Applications for this Company
Contact	Chih-Lu Hsu 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	05/11/2018
Decision Date	06/21/2019
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