BeamSite
FDA 510(k) K200940 · Doseoptics, LLC
510(k) numberK200940
Submission
- Device name
- BeamSite
- Applicant
- Doseoptics, LLC
Lebanon, NH, US - Received
- April 8, 2020
- Decision date
- December 11, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was BeamSite cleared by the FDA?
BeamSite (K200940) received a 510(k) decision of Substantially Equivalent on December 11, 2020, 247 days after the submission was received.
What is the product code of K200940?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.