FDA 510(k)

CER-S

Número K: K193177 · 2020-08-26

Data da decisão2020-08-26

Código do produtoMLO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CER-S is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocalm. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K193177. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CER-S?

CER-S is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Cardiocalm. The 510(k) number is K193177.

When did CER-S receive FDA 510(k) clearance?

CER-S received FDA 510(k) clearance on 2020-08-26, under 510(k) number K193177.

Who is the listed applicant for CER-S?

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

What is the FDA product code for CER-S?

The FDA product code for CER-S is MLO.

Dispositivos Relacionados (Código: MLO)

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.

K261580ZBPro Diagnostic (Version 2.0)Zbeats, Inc.K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbH K240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd.K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.K182030Faros MobileBittium Biosignals , Ltd.

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.