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FDA 510(k)

NeoBeat, NeoBeat Mini

K-Number: K232111 · 2024-06-25

ApplicantLaerdal Medical AS
Decision Date2024-06-25
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NeoBeat, NeoBeat Mini is the device name listed in this FDA 510(k) record. The listed applicant is Laerdal Medical AS. It received FDA 510(k) clearance on 2024-06-25 under 510(k) 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. The listed applicant is Laerdal Medical AS. The 510(k) number is K232111.

When did NeoBeat, NeoBeat Mini receive FDA 510(k) clearance?

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

Who is the listed applicant for NeoBeat, NeoBeat Mini?

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

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

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

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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.

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