510(k) K240646
K240646 is an FDA 510(k) premarket notification submitted by Somnomed Technologies Inc., Doing Business AS Remware for the device "DreamClear". The FDA issued a decision of Substantially Equivalent on September 4, 2024. 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
- September 4, 2024
- Date Received
- March 7, 2024
- 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