Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

WARD-CSS (v1.2.x)

K-Number: K241958 · 2025-02-14

ApplicantWard 24/7 Aps
Decision Date2025-02-14
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WARD-CSS (v1.2.x) is a medical device manufactured by Ward 24/7 Aps. It received FDA 510(k) clearance on 2025-02-14 under approval number K241958. 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 WARD-CSS (v1.2.x)?

WARD-CSS (v1.2.x) is a medical device that received FDA 510(k) clearance on 2025-02-14. It is manufactured by Ward 24/7 Aps. The 510(k) number is K241958.

When was WARD-CSS (v1.2.x) approved by the FDA?

WARD-CSS (v1.2.x) received FDA 510(k) clearance on 2025-02-14, under approval number K241958.

What company makes WARD-CSS (v1.2.x)?

WARD-CSS (v1.2.x) is manufactured by Ward 24/7 Aps.

What is the FDA product code for WARD-CSS (v1.2.x)?

The FDA product code for WARD-CSS (v1.2.x) is MWI.

Related Devices (Code: MWI)

Official Source

View on FDA Database →

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