FDA 510(k)

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

K-Number: K222977 · 2023-02-17

Decision Date2023-02-17

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip is a medical device manufactured by Macromedics BV. It received FDA 510(k) clearance on 2023-02-17 under approval number K222977. 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 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. It is manufactured by Macromedics BV. The 510(k) number is K222977.

When was DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip approved by the FDA?

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

What company makes DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip?

DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip is manufactured by Macromedics BV.

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.

Other Devices by Macromedics BV

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

Related Devices (Code: IYE)

K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. K161400ImagingRing SystemMedphoton GmbH K162468ClearCheckRadformation K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC K162265CushionCast Moldable CushionsIzi Medical Products, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.