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FDA 510(k)

FlexBoardTM, EagleBoardTM, BreastBoard SXTM

K-Number: K213439 · 2022-06-24

ApplicantMacromedics BV
Decision Date2022-06-24
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FlexBoardTM, EagleBoardTM, BreastBoard SXTM is a medical device manufactured by Macromedics BV. It received FDA 510(k) clearance on 2022-06-24 under approval number K213439. 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 FlexBoardTM, EagleBoardTM, BreastBoard SXTM?

FlexBoardTM, EagleBoardTM, BreastBoard SXTM is a medical device that received FDA 510(k) clearance on 2022-06-24. It is manufactured by Macromedics BV. The 510(k) number is K213439.

When was FlexBoardTM, EagleBoardTM, BreastBoard SXTM approved by the FDA?

FlexBoardTM, EagleBoardTM, BreastBoard SXTM received FDA 510(k) clearance on 2022-06-24, under approval number K213439.

What company makes FlexBoardTM, EagleBoardTM, BreastBoard SXTM?

FlexBoardTM, EagleBoardTM, BreastBoard SXTM is manufactured by Macromedics BV.

What is the FDA product code for FlexBoardTM, EagleBoardTM, BreastBoard SXTM?

The FDA product code for FlexBoardTM, EagleBoardTM, BreastBoard SXTM is IYE.

Other Devices by Macromedics BV

K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set

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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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