The following data is part of a premarket notification filed by Aribex, Inc. with the FDA for Nomad Dental X-ray System.
| Device ID | K051795 |
| 510k Number | K051795 |
| Device Name: | NOMAD DENTAL X-RAY SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | ARIBEX, INC. 754 SOUTH 400 EAST Orem, UT 84097 |
| Contact | D.clark Turner |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-07-05 |
| Decision Date | 2005-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV085000420 | K051795 | 000 |
| EKAV085000150 | K051795 | 000 |
| EKAV085000040 | K051795 | 000 |
| EKAV085000030 | K051795 | 000 |
| EKAV085000020 | K051795 | 000 |
| EKAV085000010 | K051795 | 000 |
| EKAV085000000 | K051795 | 000 |