NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800— 510(k) K092699

Name: FDA 510(k) clearance K092699
Creator: U.S. Food and Drug Administration
Published: 2010-03-18

Substantially Equivalent

Neurotronics, Inc.

FDA 510(k) clearance K092699 for NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800, Substantially Equivalent on 2010-03-18. 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: 2009-09-02
Decision date: 2010-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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