FDA 510(k)

DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip

Número K: K222977 · 2023-02-17

Data da decisão2023-02-17

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip is the device name listed in this FDA 510(k) record. The listed applicant is Macromedics BV. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K222977. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip?

DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Macromedics BV. The 510(k) number is K222977.

When did DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip receive FDA 510(k) clearance?

DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip received FDA 510(k) clearance on 2023-02-17, under 510(k) number K222977.

Who is the listed applicant for DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip?

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 DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip?

The FDA product code for DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip is IYE.

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Outros registros que listam Macromedics BV como candidato(a)

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 K213439FlexBoardTM, EagleBoardTM, BreastBoard SXTM K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips

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