Ai Ray Dental X-Ray Device— 510(k) K222569

Name: FDA 510(k) clearance K222569
Creator: U.S. Food and Drug Administration
Published: 2022-11-23

Substantially Equivalent

Guilin Woodpecker Medical Instrument Co., Ltd.

FDA 510(k) clearance K222569 for Ai Ray Dental X-Ray Device, Substantially Equivalent on 2022-11-23. Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2022-08-24
Decision date: 2022-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilin, CN

Download summary PDF View on FDA.gov ↗

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