510(k) K231116
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 2024
- Date Received
- April 20, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Body Composition
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- GU
- Submission Type