FDA 510(k)

공기주먹, 발지지대, LEPS(하부 외부 위치 시스템), 침대줄

K-번호: K212909 · 2022-05-11

결정일2022-05-11

제품 코드IYE

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips is the device name listed in this FDA 510(k) record. The listed applicant is Macromedics BV. It received FDA 510(k) clearance on 2022-05-11 under 510(k) number K212909. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips?

VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips is a medical device that received FDA 510(k) clearance on 2022-05-11. The listed applicant is Macromedics BV. The 510(k) number is K212909.

When did VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips receive FDA 510(k) clearance?

VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips received FDA 510(k) clearance on 2022-05-11, under 510(k) number K212909.

Who is the listed applicant for VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips?

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 VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips?

The FDA product code for VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips is IYE.

Macromedics BV를 신청인으로 등재한 기타 기록

K250429DSPS-Prominent® 베이스플레이트, MR (113820); DSPS-Prominent® 베이스플레이트 (113120); DSPS-Prominent® 크래들-I (113140); DSPS-Prominent® 크래들-II (113150); DSPS-Prominent® 크래들-III (113160); DSPS-Prominent® 크래들-IV (113170); DSPS-Prominent® 크래들-VI (113180); DSPS-Prominent® 크래들-VII (113260); 마스크 DSPS®-PROSCVRL 세트/5 (113760); 마스크 DSPS®-PROSC 세트/5 (113770); 마스크 DSPS®-PROSCVR 세트/5 (113780); 마스크 DSPS®-PROSCL 세트/5 (113790); 마스크 DSPS®-PROSHVRL 세트/5 (113890); 마스크 DSPS®-PROSH K222977DSPS-Prominent™ 마스크; DSPS-Prominent™ 베이스플레이트, MR; CouchStrip K213439FlexBoardTM, EagleBoardTM, BreastBoard SXTM

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