The following data is part of a premarket notification filed by Objectivision Pty Ltd. with the FDA for Accumap Automatic Perimeter.
Device ID | K022304 |
510k Number | K022304 |
Device Name: | ACCUMAP AUTOMATIC PERIMETER |
Classification | Stimulator, Photic, Evoked Response |
Applicant | OBJECTIVISION PTY LTD. 185 JORDAN RD. Troy, NY 12180 |
Contact | Fred Henry |
Correspondent | Fred Henry OBJECTIVISION PTY LTD. 185 JORDAN RD. Troy, NY 12180 |
Product Code | GWE |
CFR Regulation Number | 882.1890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-16 |
Decision Date | 2003-11-14 |
Summary: | summary |