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FDA 510(k)

LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream

K-번호: K153719 · 2016-06-03

신청자Honeywell Hommed, LLC
결정일2016-06-03
제품 코드DRG
자문 위원회CV
결정Substantially Equivalent

기기 요약

LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream is the device name listed in this FDA 510(k) record. The listed applicant is Honeywell Hommed, LLC. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K153719. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream?

LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Honeywell Hommed, LLC. The 510(k) number is K153719.

When did LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream receive FDA 510(k) clearance?

LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream received FDA 510(k) clearance on 2016-06-03, under 510(k) number K153719.

Who is the listed applicant for LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream?

The FDA 510(k) record lists Honeywell Hommed, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream?

The FDA product code for LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream is DRG.

관련 임상시험

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751의료 기기 인공지능 보조 유로-캠 캐터터 평가 시스템:膀胱癌 진단을 위한NOT_YET_RECRUITING

관련 기기 (코드: DRG)

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

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