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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 the device name listed in this FDA 510(k) record. The listed applicant is Osstell AB. It received FDA 510(k) clearance on 2019-08-22 under 510(k) 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. The listed applicant is Osstell AB. The 510(k) number is K181888.

When did Osstell Beacon receive FDA 510(k) clearance?

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

Who is the listed applicant for Osstell Beacon?

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

What is the FDA product code for Osstell Beacon?

The FDA product code for Osstell Beacon is EKX.

Related Devices (Code: EKX)

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.

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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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