The following data is part of a premarket notification filed by Diopsys Inc. with the FDA for Enfanttm.
| Device ID | K043491 |
| 510k Number | K043491 |
| Device Name: | ENFANTTM |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | DIOPSYS INC. 16 CHAPIN ROAD SUITE 911 P.O. BOX 672 Pine Brook, NJ 07058 |
| Contact | Joseph Fontanetta |
| Correspondent | Joseph Fontanetta DIOPSYS INC. 16 CHAPIN ROAD SUITE 911 P.O. BOX 672 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 | 2004-12-17 |
| Decision Date | 2005-03-16 |
| Summary: | summary |