Cleared Traditional

NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800

K092699 · Neurotronics, Inc. · Neurology
Mar 2010
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K092699 is an FDA 510(k) clearance for the NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Neurotronics, Inc. (Gainesville, US). The FDA issued a Cleared decision on March 18, 2010, 197 days after receiving the submission on September 2, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K092699 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2009
Decision Date March 18, 2010
Days to Decision 197 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWL — Amplifier, Physiological Signal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1835