Nomad Sleep System Recorder, Model PMU800
FDA 510(k) K092699 · Neurotronics, Inc.
510(k) numberK092699
Submission
- Device name
- Nomad Sleep System Recorder, Model PMU800
- Applicant
- Neurotronics, Inc.
Gainesville, FL, US - Received
- September 2, 2009
- Decision date
- March 18, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Nomad Sleep System Recorder, Model PMU800 cleared by the FDA?
Nomad Sleep System Recorder, Model PMU800 (K092699) received a 510(k) decision of Substantially Equivalent on March 18, 2010, 197 days after the submission was received.
What is the product code of K092699?
The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.