FDA 510(k)

NomadAir PMU810

K-Number: K220631 · 2022-07-15

Decision Date2022-07-15

Product CodeGWL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NomadAir PMU810 is a medical device manufactured by Neurotronics, Inc.. It received FDA 510(k) clearance on 2022-07-15 under approval number K220631. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NomadAir PMU810?

NomadAir PMU810 is a medical device that received FDA 510(k) clearance on 2022-07-15. It is manufactured by Neurotronics, Inc.. The 510(k) number is K220631.

When was NomadAir PMU810 approved by the FDA?

NomadAir PMU810 received FDA 510(k) clearance on 2022-07-15, under approval number K220631.

What company makes NomadAir PMU810?

NomadAir PMU810 is manufactured by Neurotronics, Inc..

What is the FDA product code for NomadAir PMU810?

The FDA product code for NomadAir PMU810 is GWL.

Other Devices by Neurotronics, Inc.

K161650Polysmith Sleep System, Model NTI7593 K181709Serenity Piezo Sensor, Serenity Thermocouple Sensor K173868Serenity Body Position Sensor, Serenity RIP Sensors

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.