ACCUMAP AUTOMATIC PERIMETER


Device Classification Name

stimulator, photic, evoked response

510(k) Number K022304
Device Name ACCUMAP AUTOMATIC PERIMETER
Original Applicant
OBJECTIVISION PTY LTD.
185 jordan rd.
troy, 
NY 
12180

Original Contact fred henry
Regulation Number 882.1890
Classification Product Code
GWE  
Date Received 07/16/2002
Decision Date 11/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No