FDA 510(k) Premarket Notification K994242: BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT

Submission Details & Decision

Normalized public record details for 510(k) notification K994242.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K994242

Applicant / Sponsor

Bodystat , Ltd.

Device Name

BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT

Product Code

MNW

Decision Date

2000-03-15

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

1999-12-16

Related Establishments / Registrations

CONAIR LLC. Registration: 1222304 View Registration
Omron Healthcare, Inc. Registration: 1450057 View Registration
TANITA INTERNATIONAL LTD. Registration: 3002684743 View Registration
InBody Co, Ltd. Registration: 3003074886 View Registration
BIOSPACE INC. Registration: 3003193933 View Registration
SECA Registration: 3003587684 View Registration
OnCore Manufacturing Registration: 3003695829 View Registration
HIGI SH LLC Registration: 3003703880 View Registration
ANDON HEALTH CO., LTD Registration: 3003741676 View Registration
Simpro Registration: 3004485927 View Registration
Impedimed Limited Registration: 3004782476 View Registration
STAR ELITE Registration: 3004835896 View Registration
FOOK TIN TECHNOLOGIES LIMITED Registration: 3005374248 View Registration
IMPEDIMED, INC. Registration: 3005699942 View Registration
MEASUREMENT LTD. Registration: 3005707783 View Registration
Shenzhen Shine Industrial Co., Ltd. Registration: 3006026335 View Registration
LD TECHNOLOGY LLC Registration: 3006146787 View Registration
KRELL PRECISION (YANGZHOU) CO., LTD Registration: 3006570831 View Registration
SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO., LTD. Registration: 3006624940 View Registration
BODYSTAT LTD Registration: 3006948217 View Registration
CHA'S ELECTRONIC INDUSTRIES (SHENZHEN) COMPANY LIMITED Registration: 3007649409 View Registration
Tanita Corporation of Akita, Ltd Registration: 3008240972 View Registration
Dongguan Tanita Health Equipment Co., Ltd. Registration: 3008262243 View Registration
Zhongshan Transtek Electronics Co., Ltd Registration: 3008485370 View Registration
FITBIT LLC Registration: 3009253624 View Registration
Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd Registration: 3010288146 View Registration
MENDTRONIX, INC. Registration: 3010844918 View Registration
CONMO ELECTRONIC COMPANY LIMITED Registration: 3010968402 View Registration
Greater Goods, LLC Registration: 3011065399 View Registration
VIVE Health LLC Registration: 3011191255 View Registration
CSA SERVICE SOLUTIONS, LLC Registration: 3015522053 View Registration
ZHONGSHAN JINLI ELECTRONIC WEIGHING EQUIPMENT CO., LTD. Registration: 3017894657 View Registration
INBODY BWA, INC. Registration: 3027717071 View Registration
OMRON HEALTHCARE CO., LTD. Registration: 8030245 View Registration
SELVAS Healthcare, Inc. Registration: 9616164 View Registration
TANITA CORP. Registration: 9680010 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.