ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)— 510(k) K213497

Name: FDA 510(k) clearance K213497
Creator: U.S. Food and Drug Administration
Published: 2021-11-15

Substantially Equivalent

H&abyz Co., Ltd.

FDA 510(k) clearance K213497 for ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW), Substantially Equivalent on 2021-11-15. 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: 2021-11-01
Decision date: 2021-11-15
Decision: Substantially Equivalent
Clearance type: Special
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.