FDA 510(k)

c-med0 alpha

K-Number: K253436 · 2026-04-30

Decision Date2026-04-30

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

c-med0 alpha is the device name listed in this FDA 510(k) record. The listed applicant is Cosinuss GmbH. It received FDA 510(k) clearance on 2026-04-30 under 510(k) number K253436. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the c-med0 alpha?

c-med0 alpha is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Cosinuss GmbH. The 510(k) number is K253436.

When did c-med0 alpha receive FDA 510(k) clearance?

c-med0 alpha received FDA 510(k) clearance on 2026-04-30, under 510(k) number K253436.

Who is the listed applicant for c-med0 alpha?

The FDA 510(k) record lists Cosinuss GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for c-med0 alpha?

The FDA product code for c-med0 alpha is MWI.

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo Corporation K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.