KaVo NOMAD Pro 2 Handheld X-ray System

Unit, X-ray, Extraoral With Timer

Aribex

The following data is part of a premarket notification filed by Aribex with the FDA for Kavo Nomad Pro 2 Handheld X-ray System.

Pre-market Notification Details

Device IDK173319
510k NumberK173319
Device Name:KaVo NOMAD Pro 2 Handheld X-ray System
ClassificationUnit, X-ray, Extraoral With Timer
Applicant Aribex 11727 Fruehauf Drive Charlotte,  NC  28273
ContactErika Martin
CorrespondentErika Martin
Aribex 11727 Fruehauf Drive Charlotte,  NC  28273
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-20
Decision Date2017-11-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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