The following data is part of a premarket notification filed by Aribex, Inc. with the FDA for Nomad Pro X-ray System.
| Device ID | K081664 |
| 510k Number | K081664 |
| Device Name: | NOMAD PRO X-RAY SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | ARIBEX, INC. 744 SOUTH 400 EAST Orem, UT 84651 |
| Contact | D. Clark Turner |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-06-13 |
| Decision Date | 2008-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV085000280 | K081664 | 000 |
| EKAV085000260 | K081664 | 000 |
| EKAV085000250 | K081664 | 000 |
| EKAV085000220 | K081664 | 000 |
| EKAV085000210 | K081664 | 000 |