Morph— 510(k) K260032

Substantially Equivalent

BeauBrain Healthcare, Inc.

FDA 510(k) clearance K260032 for Morph, Substantially Equivalent on 2026-05-13. Applicant: BeauBrain Healthcare, Inc.. Device class: 2.

Clearance details

Applicant: BeauBrain Healthcare, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-01-06
Decision date: 2026-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, 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.