The following data is part of a premarket notification filed by Diopsys Inc. with the FDA for Diopsys Nova Vep Vision Testing System.
| Device ID | K101763 |
| 510k Number | K101763 |
| Device Name: | DIOPSYS NOVA VEP VISION TESTING SYSTEM |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | DIOPSYS INC. 44 COUNTRYWOOD DRIVE Pine Brook, NJ 07058 |
| Contact | Richard Hettenbach |
| Correspondent | Richard Hettenbach DIOPSYS INC. 44 COUNTRYWOOD DRIVE Pine Brook, NJ 07058 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-23 |
| Decision Date | 2011-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850514007107 | K101763 | 000 |
| 00850514007008 | K101763 | 000 |
| 00850514007015 | K101763 | 000 |
| 00850514007022 | K101763 | 000 |
| 00850514007039 | K101763 | 000 |
| 00850514007046 | K101763 | 000 |
| 00850514007053 | K101763 | 000 |
| 00850514007077 | K101763 | 000 |
| 00850514007084 | K101763 | 000 |
| 00850514007091 | K101763 | 000 |
| 20850514007033 | K101763 | 000 |