MODI System— 510(k) K260062

Substantially Equivalent

DreaMed Diabetes, Ltd.

FDA 510(k) clearance K260062 for MODI System, Substantially Equivalent on 2026-09-08. Applicant: DreaMed Diabetes, Ltd.. Device class: 2.

Clearance details

Applicant: DreaMed Diabetes, Ltd.
Product code: Code QRX
Device class: Class 2
Regulation: 21 CFR 862.1358
Advisory panel: Clinical Chemistry
Date received: 2026-01-08
Decision date: 2026-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petah Tikva, IL

Download summary PDF View on FDA.gov ↗

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More clearances from DreaMed Diabetes, Ltd.

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