The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Eva Digital Dental X-ray System.
| Device ID | K030647 |
| 510k Number | K030647 |
| Device Name: | EVA DIGITAL DENTAL X-RAY SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | AFP IMAGING CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-ccullinane |
| Correspondent | Mary Mcnamara-ccullinane AFP IMAGING CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-28 |
| Decision Date | 2003-03-20 |
| Summary: | summary |