The following data is part of a premarket notification filed by Aribex with the FDA for Kavo Nomad Pro 2 Handheld X-ray System.
| Device ID | K173319 |
| 510k Number | K173319 |
| Device Name: | KaVo NOMAD Pro 2 Handheld X-ray System |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | Aribex 11727 Fruehauf Drive Charlotte, NC 28273 |
| Contact | Erika Martin |
| Correspondent | Erika Martin Aribex 11727 Fruehauf Drive Charlotte, NC 28273 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-20 |
| Decision Date | 2017-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV101377890 | K173319 | 000 |
| D090085006210 | K173319 | 000 |
| D090085006220 | K173319 | 000 |
| D090101329290 | K173319 | 000 |
| D090101329300 | K173319 | 000 |
| D090101377880 | K173319 | 000 |
| EKAV085006210 | K173319 | 000 |
| EKAV085006220 | K173319 | 000 |
| EKAV101329290 | K173319 | 000 |
| EKAV101329300 | K173319 | 000 |
| EKAV101377880 | K173319 | 000 |
| EKAV101320400 | K173319 | 000 |
| EKAV101320410 | K173319 | 000 |
| D090101320410 | K173319 | 000 |