510(k) K231116

Multi-parameter detector by Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. — Product Code MNW

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