FlexBoardTM, EagleBoardTM, BreastBoard SXTM
FDA 510(k) K213439 · Macromedics BV
510(k) numberK213439
Submission
- Device name
- FlexBoardTM, EagleBoardTM, BreastBoard SXTM
- Applicant
- Macromedics BV
Moordrecht, NL - Received
- October 25, 2021
- Decision date
- June 24, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was FlexBoardTM, EagleBoardTM, BreastBoard SXTM cleared by the FDA?
FlexBoardTM, EagleBoardTM, BreastBoard SXTM (K213439) received a 510(k) decision of Substantially Equivalent on June 24, 2022, 242 days after the submission was received.
What is the product code of K213439?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.