510(k) K223676
K223676 is an FDA 510(k) premarket notification submitted by Brainmatterz, LLC for the device "SomniCheck". The FDA issued a decision of Substantially Equivalent on June 1, 2023. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 1, 2023
- Date Received
- December 8, 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