The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Eva Select Digital Dental Imaging System.
| Device ID | K123419 |
| 510k Number | K123419 |
| Device Name: | EVA SELECT DIGITAL DENTAL IMAGING SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | AFP IMAGING CORP. 8870 RAVELLO CT. Naples, FL 34114 |
| Contact | Daniel Kamm, P.e. |
| Correspondent | Daniel Kamm, P.e. AFP IMAGING CORP. 8870 RAVELLO CT. Naples, FL 34114 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-06 |
| Decision Date | 2012-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D83399924908000 | K123419 | 000 |
| D83399924132050 | K123419 | 000 |
| D83399924132000 | K123419 | 000 |
| D83399924131050 | K123419 | 000 |
| D83399924131000 | K123419 | 000 |
| D83399924122050 | K123419 | 000 |
| D83399924122000 | K123419 | 000 |
| D83399924121050 | K123419 | 000 |
| D83399924121000 | K123419 | 000 |