510(k) K220631
K220631 is an FDA 510(k) premarket notification submitted by Neurotronics, Inc. for the device "NomadAir PMU810". The FDA issued a decision of Substantially Equivalent on July 15, 2022. 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
- July 15, 2022
- Date Received
- March 4, 2022
- 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