Qraycam PRO— 510(k) K221275

Substantially Equivalent

AIOBIO Co., Ltd.

FDA 510(k) clearance K221275 for Qraycam PRO, Substantially Equivalent on 2024-09-04. Applicant: AIOBIO Co., Ltd.. Device class: 2.

Clearance details

Applicant: AIOBIO Co., Ltd.
Product code: Code NBL
Device class: Class 2
Regulation: 21 CFR 872.1745
Advisory panel: Dental
Date received: 2022-05-02
Decision date: 2024-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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