FDA 510(k) Application Details - K023245

Device Classification Name	Tonometer, Analyzer, Ocular Blood Flow   More FDA Info for this Device
510(K) Number	K023245
Device Name	Tonometer, Analyzer, Ocular Blood Flow
Applicant	PARADIGM MEDICAL INDUSTRIES, INC. 2355 SOUTH 1070 WEST SALT LAKE CITY, UT 84119 US Other 510(k) Applications for this Company
Contact	DAVID M SILVER Other 510(k) Applications for this Contact
Regulation Number	886.1930   More FDA Info for this Regulation Number
Classification Product Code	NJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2002
Decision Date	10/21/2002
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