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)

NeoBeat, NeoBeat Mini

K-Number: K232111 · 2024-06-25

Decision Date2024-06-25
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NeoBeat, NeoBeat Mini is a medical device manufactured by Laerdal Medical AS. It received FDA 510(k) clearance on 2024-06-25 under approval number K232111. 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 NeoBeat, NeoBeat Mini?

NeoBeat, NeoBeat Mini is a medical device that received FDA 510(k) clearance on 2024-06-25. It is manufactured by Laerdal Medical AS. The 510(k) number is K232111.

When was NeoBeat, NeoBeat Mini approved by the FDA?

NeoBeat, NeoBeat Mini received FDA 510(k) clearance on 2024-06-25, under approval number K232111.

What company makes NeoBeat, NeoBeat Mini?

NeoBeat, NeoBeat Mini is manufactured by Laerdal Medical AS.

What is the FDA product code for NeoBeat, NeoBeat Mini?

The FDA product code for NeoBeat, NeoBeat Mini is MWI.

Other Devices by Laerdal Medical AS

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.