FDA 510(k)

FlexBoardTM, EagleBoardTM, BreastBoard SXTM

N.º K: K213439 · 2022-06-24

Fecha de decisión2022-06-24

Código de productoIYE

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

FlexBoardTM, EagleBoardTM, BreastBoard SXTM is the device name listed in this FDA 510(k) record. The listed applicant is Macromedics BV. It received FDA 510(k) clearance on 2022-06-24 under 510(k) number K213439. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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. The listed applicant is Macromedics BV. The 510(k) number is K213439.

When did FlexBoardTM, EagleBoardTM, BreastBoard SXTM receive FDA 510(k) clearance?

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

Who is the listed applicant for FlexBoardTM, EagleBoardTM, BreastBoard SXTM?

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

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

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

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Otros registros que enlistan a Macromedics BV como solicitante

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 K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips

Dispositivos relacionados (Código: IYE)

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Fuente oficial

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