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FDA 510(k)

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K

N.º K: K220177 · 2022-09-01

SolicitanteMagnus Medical, Inc.
Fecha de decisión2022-09-01
Código de productoOBP
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K is the device name listed in this FDA 510(k) record. The listed applicant is Magnus Medical, Inc.. It received FDA 510(k) clearance on 2022-09-01 under 510(k) number K220177. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K?

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K is a medical device that received FDA 510(k) clearance on 2022-09-01. The listed applicant is Magnus Medical, Inc.. The 510(k) number is K220177.

When did Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K receive FDA 510(k) clearance?

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K received FDA 510(k) clearance on 2022-09-01, under 510(k) number K220177.

Who is the listed applicant for Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K?

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

What is the FDA product code for Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K?

The FDA product code for Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K is OBP.

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Fuente oficial

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