Digital Intraoral X-ray Sensor— 510(k) K220277

Name: FDA 510(k) clearance K220277
Creator: U.S. Food and Drug Administration
Published: 2022-02-17

Substantially Equivalent

Shenzhen Xpectvision Technology Co., Ltd.

FDA 510(k) clearance K220277 for Digital Intraoral X-ray Sensor, Substantially Equivalent on 2022-02-17. Applicant: Shenzhen Xpectvision Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Xpectvision Technology Co., Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2022-01-31
Decision date: 2022-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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