A1417MCW/A1717MCW/F1417MCW— 510(k) K223930

Substantially Equivalent

H&abyz Co., Ltd.

FDA 510(k) clearance K223930 for A1417MCW/A1717MCW/F1417MCW, Substantially Equivalent on 2023-03-06. Applicant: H&abyz Co., Ltd.. Device class: 2.

Clearance details

Applicant: H&abyz Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2022-12-30
Decision date: 2023-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-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.