DeviceClearance

NOMAD PRO X-RAY SYSTEM— 510(k) K081664

Substantially Equivalent

Aribex, Inc.

FDA 510(k) clearance K081664 for NOMAD PRO X-RAY SYSTEM, Substantially Equivalent on 2008-06-23. Applicant: Aribex, Inc.. Device class: 2.

Clearance details

Applicant
Aribex, Inc.
Product code
Code EHD
Device class
Class 2
Regulation
21 CFR 872.1800
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Orem, UT, US
Download summary PDFView on FDA.gov ↗

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Recalls naming K081664

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081664.

Data sourced from openFDA. This site is unofficial and independent of the FDA.