FDA 510(k)

Ecomed Disposable Angiographic Syringes

K-번호: K162088 · 2017-01-27

결정일2017-01-27

제품 코드DXT

자문 위원회의료장비 규제 텍스트 번역 [회사명]의 [제품명]은 미국 식약국(FDA)에 등록된 의료장비로, 510(k) 신청을 통해 승인받았습니다. PMA(Premarket Approval) 신청이 진행 중이며, 연구 등록 번호(NCT)는 [NCT 번호]입니다. 논문 등록 번호(PMID)는 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL] 정책: medical-regulatory-v1

결정Substantially Equivalent

기기 요약

Ecomed Disposable Angiographic Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Ecomed Solutions, LLC. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K162088. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Ecomed Disposable Angiographic Syringes?

Ecomed Disposable Angiographic Syringes is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Ecomed Solutions, LLC. The 510(k) number is K162088.

When did Ecomed Disposable Angiographic Syringes receive FDA 510(k) clearance?

Ecomed Disposable Angiographic Syringes received FDA 510(k) clearance on 2017-01-27, under 510(k) number K162088.

Who is the listed applicant for Ecomed Disposable Angiographic Syringes?

FDA 510(k) 기록은 Ecomed Solutions, LLC를 신청자로 나열하지만, 이것만으로 장비 제조업체로서의 인정을 확립하지는 않습니다.

What is the FDA product code for Ecomed Disposable Angiographic Syringes?

The FDA product code for Ecomed Disposable Angiographic Syringes is DXT.

Ecomed Solutions, LLC를 신청인으로 등재한 기타 기록

K254123Ecomed Disposable Administration Sets K234129Ecomed Disposable Administration Sets

관련 기기 (코드: DXT)

K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable SyrFortis Biosolutions Company Limited K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)Acist Medical Systems, Inc.K252653ACIST Pro 진단 시스템 (019304); 처리 유닛 베드 마운트; AngioTouch 모듈; ACIST Pro 카트; 단일 트랜서듀어 케이블; 트리플 트랜서듀어 케이블Acist Medical Systems, Inc.K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, Inc.

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