FDA 510(k)

Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17

Número K: K221616 · 2022-08-01

Data da decisão2022-08-01

Código do produtoMHX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 is the device name listed in this FDA 510(k) record. The listed applicant is Caf Medical Solutions, Inc.. It received FDA 510(k) clearance on 2022-08-01 under 510(k) number K221616. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17?

Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 is a medical device that received FDA 510(k) clearance on 2022-08-01. The listed applicant is Caf Medical Solutions, Inc.. The 510(k) number is K221616.

When did Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 receive FDA 510(k) clearance?

Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 received FDA 510(k) clearance on 2022-08-01, under 510(k) number K221616.

Who is the listed applicant for Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17?

The FDA 510(k) record lists Caf Medical Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17?

The FDA product code for Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 is MHX.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Caf Medical Solutions, Inc. como candidato(a)

K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 K220362LE-12CH

Dispositivos Relacionados (Código: MHX)

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland Oy K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.