FDA 510(k)

DSPS-Prominent™ 面罩；DSPS-Prominent™ 底座，MR；CouchStrip

K号: K222977 · 2023-02-17

决定日期2023-02-17

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Macromedics BV为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250429DSPS-Prominent® 底座，MR（113820）；DSPS-Prominent® 底座（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 K212909真空垫，足部支撑，LEPS（下肢定位系统），床条

官方来源

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