FDA 510(k) Application Details - K182491

Device Classification Name	Tonometer, Manual   More FDA Info for this Device
510(K) Number	K182491
Device Name	Tonometer, Manual
Applicant	Takagi Seiko Co., Ltd. 330-2 Nakano-Shi 383-8585 JP Other 510(k) Applications for this Company
Contact	Shinya Kitamura Other 510(k) Applications for this Contact
Regulation Number	886.1930   More FDA Info for this Regulation Number
Classification Product Code	HKY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2018
Decision Date	12/10/2018
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