FDA 510(k)

Pure EP

N.º K: K180805 · 2018-08-08

Fecha de decisión2018-08-08

Código de productoDQK

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Pure EP is the device name listed in this FDA 510(k) record. The listed applicant is Biosig Technologies. It received FDA 510(k) clearance on 2018-08-08 under 510(k) number K180805. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Pure EP?

Pure EP is a medical device that received FDA 510(k) clearance on 2018-08-08. The listed applicant is Biosig Technologies. The 510(k) number is K180805.

When did Pure EP receive FDA 510(k) clearance?

Pure EP received FDA 510(k) clearance on 2018-08-08, under 510(k) number K180805.

Who is the listed applicant for Pure EP?

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

What is the FDA product code for Pure EP?

The FDA product code for Pure EP is DQK.

Dispositivos relacionados (Código: DQK)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K261729EnSite™ X EP SystemAbbott Medical K262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott Medical K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

Fuente oficial

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