510(k) K231116
K231116 is an FDA 510(k) premarket notification submitted by Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. for the device "Multi-parameter detector". The FDA issued a decision of Substantially Equivalent on June 15, 2024. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. has at least 1 other 510(k) clearance on record.
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