The following data is part of a premarket notification filed by Afp Imaging Corp. with the FDA for Ev Apan Digital, Model K1vsm2000.
| Device ID | K041120 |
| 510k Number | K041120 |
| Device Name: | EV APAN DIGITAL, MODEL K1VSM2000 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford, NY 10523 |
| Contact | James Johnson |
| Correspondent | James Johnson AFP IMAGING CORP. 250 CLEARBROOK RD. Elmsford, NY 10523 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-29 |
| Decision Date | 2004-08-30 |
| Summary: | summary |