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FDA 510(k)

NomadAir PMU810

K-Number: K220631 · 2022-07-15

ApplicantNeurotronics, Inc.
Decision Date2022-07-15
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NomadAir PMU810 is the device name listed in this FDA 510(k) record. The listed applicant is Neurotronics, Inc.. It received FDA 510(k) clearance on 2022-07-15 under 510(k) 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. The listed applicant is Neurotronics, Inc.. The 510(k) number is K220631.

When did NomadAir PMU810 receive FDA 510(k) clearance?

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

Who is the listed applicant for NomadAir PMU810?

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

What is the FDA product code for NomadAir PMU810?

The FDA product code for NomadAir PMU810 is GWL.

Other records listing Neurotronics, Inc. as applicant

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Related Devices (Code: GWL)

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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.

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