FDA 510(k) Application Details - K183695

Device Classification Name	More FDA Info for this Device
510(K) Number	K183695
Device Name	OrthoAnalysis Software
Applicant	Inteware Co., Ltd. 4F., No.93, Xinzheng 5th St., Taiwan, R.O.C. Minxiong Township, Chiayi Country 62145 621 CN Other 510(k) Applications for this Company
Contact	Wayne Tsai Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2018
Decision Date	09/12/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review