NomadAir PMU810— 510(k) K220631

Substantially Equivalent

Neurotronics, Inc.

FDA 510(k) clearance K220631 for NomadAir PMU810, Substantially Equivalent on 2022-07-15. Applicant: Neurotronics, Inc.. Device class: 2.

Clearance details

Applicant: Neurotronics, Inc.
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2022-03-04
Decision date: 2022-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.