Mcare System (MW-20)— 510(k) K253673

Substantially Equivalent

Marani Health, Inc.

FDA 510(k) clearance K253673 for Mcare System (MW-20), Substantially Equivalent on 2026-09-03. Applicant: Marani Health, Inc.. Device class: 2.

Clearance details

Applicant: Marani Health, Inc.
Product code: Code LQK
Device class: Class 2
Regulation: 21 CFR 884.2730
Advisory panel: Obstetrics/Gynecology
Date received: 2025-11-21
Decision date: 2026-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakdale, MN, US

Download summary PDF View on FDA.gov ↗

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