510(k) K221772
K221772 is an FDA 510(k) premarket notification submitted by New Touch Digital, Inc. for the device "NeuroRPM". The FDA issued a decision of Substantially Equivalent on March 17, 2023. The device falls under product code GYD (Transducer, Tremor), a Class II device regulated under 21 CFR 882.1950.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2023
- Date Received
- June 21, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Tremor
- Device Class
- Class II
- Regulation Number
- 882.1950
- Review Panel
- NE
- Submission Type