medilogFD— 510(k) K253562
Substantially EquivalentSchiller AG
FDA 510(k) clearance K253562 for medilogFD, Substantially Equivalent on 2026-08-14. Applicant: Schiller AG. Device class: 2.
Summary
Schiller's medilogFD is filed under product code MWJ, ambulatory electrocardiographs without analysis. The record gives no further description.
Class II, 21 CFR 870.2800. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Schiller filed from Baar, Switzerland. The substantially equivalent decision came 270 calendar days after receipt (November 17, 2025 to August 14, 2026).
Clearance details
- Applicant
- Schiller AG
- Product code
- Product code MWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baar, CH
Recent devices under product code MWJ
view allMore clearances from Schiller AG
view allAdverse events under product code MWJ
product code MWJ- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.