FDA.reportPublic FDA data

510(k) K020738

Device
AVITA BF1 (VITALIO) BODY FAT ANALYZER
Applicant
Avita Corporation
510(k) number
K020738
Product code
MNW
Decision
Substantially Equivalent (SESE)
Decision date
2003-05-22
Date received
2002-03-06
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
JENNIFER REICH
Address
3892 S. America W. Trl. Flagstaff AZ US 86001 86001

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MNW#

510(k), Device, Applicant table
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K141483BIOSPACE BODY COMPOSITION ANALYZERBiospace Corporation Limited2014-09-23
K133872ARIA WIFI SMART SCALEFitbit, Inc.2014-06-02
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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