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FDA 510(k)

BrainPulse 1100

N.º K: K170926 · 2017-04-28

SolicitanteJan Medical, Inc.
Fecha de decisión2017-04-28
Código de productoPOP
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

BrainPulse 1100 is the device name listed in this FDA 510(k) record. The listed applicant is Jan Medical, Inc.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K170926. The device is classified under product code POP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BrainPulse 1100?

BrainPulse 1100 is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Jan Medical, Inc.. The 510(k) number is K170926.

When did BrainPulse 1100 receive FDA 510(k) clearance?

BrainPulse 1100 received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170926.

Who is the listed applicant for BrainPulse 1100?

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

What is the FDA product code for BrainPulse 1100?

The FDA product code for BrainPulse 1100 is POP.

Ensayos clínicos relacionados

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.

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Fuente oficial

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