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 |