510(k) K092699
K092699 is an FDA 510(k) premarket notification submitted by Neurotronics, Inc. for the device "NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800". The FDA issued a decision of Substantially Equivalent on March 18, 2010. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Neurotronics, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2010
- Date Received
- September 2, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier, Physiological Signal
- Device Class
- Class II
- Regulation Number
- 882.1835
- Review Panel
- NE
- Submission Type