The following data is part of a premarket notification filed by Aribex, Inc. with the FDA for Nomad Md 75k V Handheld X-ray System.
| Device ID | K140723 |
| 510k Number | K140723 |
| Device Name: | NOMAD MD 75K V HANDHELD X-RAY SYSTEM |
| Classification | System, X-ray, Mobile |
| Applicant | ARIBEX, INC. 744 SOUTH 400 EAST Orem, UT 84097 |
| Contact | Christopher Dodge |
| Correspondent | Sanjay Ahuja ARIBEX, INC. 744 SOUTH 400 EAST Orem, UT 84097 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-21 |
| Decision Date | 2014-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV101152780 | K140723 | 000 |
| EKAV085004710 | K140723 | 000 |
| EKAV085004700 | K140723 | 000 |
| EKAV085001120 | K140723 | 000 |
| EKAV085000300 | K140723 | 000 |