HAD1717MC— 510(k) K200018

Substantially Equivalent

H&Abyz

FDA 510(k) clearance K200018 for HAD1717MC, Substantially Equivalent on 2020-01-31. Applicant: H&Abyz. Device class: 2.

Clearance details

Applicant: H&Abyz
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2020-01-03
Decision date: 2020-01-31
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.