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FDA 510(k)

Osstell Beacon

K-Number: K181888 · 2019-08-22

ApplicantOsstell AB
Decision Date2019-08-22
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Osstell Beacon is a medical device manufactured by Osstell AB. It received FDA 510(k) clearance on 2019-08-22 under approval number K181888. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Osstell Beacon?

Osstell Beacon is a medical device that received FDA 510(k) clearance on 2019-08-22. It is manufactured by Osstell AB. The 510(k) number is K181888.

When was Osstell Beacon approved by the FDA?

Osstell Beacon received FDA 510(k) clearance on 2019-08-22, under approval number K181888.

What company makes Osstell Beacon?

Osstell Beacon is manufactured by Osstell AB.

What is the FDA product code for Osstell Beacon?

The FDA product code for Osstell Beacon is EKX.

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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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