FDA 510(k)

BeamSite

K-Number: K200940 · 2020-12-11

Decision Date2020-12-11

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BeamSite is the device name listed in this FDA 510(k) record. The listed applicant is Doseoptics, LLC. It received FDA 510(k) clearance on 2020-12-11 under 510(k) number K200940. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BeamSite?

BeamSite is a medical device that received FDA 510(k) clearance on 2020-12-11. The listed applicant is Doseoptics, LLC. The 510(k) number is K200940.

When did BeamSite receive FDA 510(k) clearance?

BeamSite received FDA 510(k) clearance on 2020-12-11, under 510(k) number K200940.

Who is the listed applicant for BeamSite?

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

What is the FDA product code for BeamSite?

The FDA product code for BeamSite is IYE.

Other records listing Doseoptics, LLC as applicant

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.

K212606BeamSite

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Official Source

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