medilogFD— 510(k) K253562

Name: FDA 510(k) clearance K253562
Creator: U.S. Food and Drug Administration
Published: 2026-08-14

Substantially Equivalent

Schiller AG

FDA 510(k) clearance K253562 for medilogFD, Substantially Equivalent on 2026-08-14. Applicant: Schiller AG. Device class: 2.

Clearance details

Applicant: Schiller AG
Product code: Code MWJ
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2025-11-17
Decision date: 2026-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code MWJ

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K253384 — mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)2026-06-25
K252839 — ZywieZ3 Sensor & Adhesive2026-06-18
K231424 — HeartBeam AIMIGo(TM) System2024-12-13
K233864 — ASSURE Wearable ECG2024-05-07
K212317 — Eclipse MINI Model 989002022-11-07

More clearances from Schiller AG

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K221056 — ARGUS PB-30002023-07-06
K183425 — CARDIOVIT AT-102 G22020-03-02
K170182 — CARDIOVIT FT-12017-07-19
K152043 — Diagnostic Station DS202016-05-06
K101619 — WELCH ALLYN 1500 PATIENT MONITOR2010-11-12

Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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