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510(k) K231116

Device
Multi-parameter detector
Applicant
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
510(k) number
K231116
Product code
MNW
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-15
Date received
2023-04-20
Regulation
870.2770
Classification name
Analyzer, Body Composition
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jerry Liang
Address
283rd S. Min'An Rd., Xiaolan Town, Zhongshan City, Guangdong, China Zhongshan CN 528400 528400

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MNW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140045BODY COMPOSITION ANALYZERJawon Medical Co., Ltd.2015-02-18
K141483BIOSPACE BODY COMPOSITION ANALYZERBiospace Corporation Limited2014-09-23
K133872ARIA WIFI SMART SCALEFitbit, Inc.2014-06-02
K140594BODY FAT ANALYZER AND SCALEConmo Electronic Company Limited2014-05-30
K130777INBODYBiospace Corporation Limited2013-11-25
K130856BIA / VITALITY ANALYZERIpgdx, LLC2013-11-25
K130952PRECISION ONE LIFECARE; DETECTO; DETECTOPrecision One Lifecare, Ltd.2013-09-26
K131394TRANSTEK GLASS BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.2013-09-18
K130311TRANSTEK BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.2013-05-30
K122388SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514Seca GmbH & Co. KG2013-05-02
K123228INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)Biospace Corporation Limited2013-03-08
K123781TRANSTEK GLASS BODY FAT ANALYZERZhongshan Transtek Electronics Co., Ltd.2013-01-09
K122976BODY FAT SCALE MODEL SF-371Shenzhen Belter Health Measurement and Analysis TE2013-01-04
K121971WITHINGS, SMART BODY SCALEZhongshan Transtek Electronics Co., Ltd.2012-09-27
K120896WI-FI BODY SCALEAndon Health Co, Ltd.2012-07-26