510(k) K221924
K221924 is an FDA 510(k) premarket notification submitted by Gnc Holdings, LLC for the device "Digital Routines". The FDA issued a decision of Substantially Equivalent on March 15, 2023. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2023
- Date Received
- July 1, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Drug Dose
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- CH
- Submission Type