The following data is part of a premarket notification filed by Smartlight, Inc. with the FDA for Smartlight Digital Film Viewer, Models Sl 4000plus, Sl 2000plus.
| Device ID | K991302 |
| 510k Number | K991302 |
| Device Name: | SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS |
| Classification | Illuminator, Radiographic-film |
| Applicant | SMARTLIGHT, INC. 241 MAIN ST. Hackensack, NJ 07601 |
| Contact | A. Robert Sohoval |
| Correspondent | A. Robert Sohoval SMARTLIGHT, INC. 241 MAIN ST. Hackensack, NJ 07601 |
| Product Code | IXC |
| CFR Regulation Number | 892.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-16 |
| Decision Date | 1999-06-01 |
| Summary: | summary |