c-med0 alpha— 510(k) K253436
Substantially EquivalentCosinuss GmbH
FDA 510(k) clearance K253436 for c-med0 alpha, Substantially Equivalent on 2026-04-30. Applicant: Cosinuss GmbH. Device class: 2.
Summary
Cosinuss GmbH's c-med0 alpha is filed under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 870.2300. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Cosinuss filed from Munich, Germany. The decision came 211 calendar days after FDA received it (October 1, 2025 to April 30, 2026).
Clearance details
- Applicant
- Cosinuss GmbH
- Product code
- Product code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
Recent devices under product code MWI
view allAdverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
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.