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 |