FDA 510(k)

Gravador ECG Portátil MiCor A100

Número K: K162665 · 2018-01-26

Data da decisão2018-01-26

Código do produtoDPS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

MiCor A100 Wearable ECG Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Mitac International Corp.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K162665. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MiCor A100 Wearable ECG Recorder?

MiCor A100 Wearable ECG Recorder is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Mitac International Corp.. The 510(k) number is K162665.

When did MiCor A100 Wearable ECG Recorder receive FDA 510(k) clearance?

MiCor A100 Wearable ECG Recorder received FDA 510(k) clearance on 2018-01-26, under 510(k) number K162665.

Who is the listed applicant for MiCor A100 Wearable ECG Recorder?

The FDA 510(k) record lists Mitac International Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiCor A100 Wearable ECG Recorder?

The FDA product code for MiCor A100 Wearable ECG Recorder is DPS.

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

Dispositivos Relacionados (Código: DPS)

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361Sistema de Análise de ECG AccurECG (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs Holter PlatformPhilips France Commercial

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.