Cleared Traditional

Multi-parameter detector

K231116 · Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd. · Cardiovascular
Jun 2024
Decision
422d
Days
Class 2
Risk

About This 510(k) Submission

K231116 is an FDA 510(k) clearance for the Multi-parameter detector, a Analyzer, Body Composition (Class II — Special Controls, product code MNW), submitted by Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on June 15, 2024, 422 days after receiving the submission on April 20, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number K231116 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2023
Decision Date June 15, 2024
Days to Decision 422 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MNW — Analyzer, Body Composition
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2770