Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HBF-1000 OMRON BODY COMPOSITION ANALYZER

K-Number: K963575 · 1997-06-13

ApplicantOmron Healthcare, Inc.
Decision Date1997-06-13
Product CodeMNW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HBF-1000 OMRON BODY COMPOSITION ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 1997-06-13 under 510(k) number K963575. The device is classified under product code MNW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HBF-1000 OMRON BODY COMPOSITION ANALYZER?

HBF-1000 OMRON BODY COMPOSITION ANALYZER is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K963575.

When did HBF-1000 OMRON BODY COMPOSITION ANALYZER receive FDA 510(k) clearance?

HBF-1000 OMRON BODY COMPOSITION ANALYZER received FDA 510(k) clearance on 1997-06-13, under 510(k) number K963575.

Who is the listed applicant for HBF-1000 OMRON BODY COMPOSITION ANALYZER?

The FDA 510(k) record lists Omron Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HBF-1000 OMRON BODY COMPOSITION ANALYZER?

The FDA product code for HBF-1000 OMRON BODY COMPOSITION ANALYZER is MNW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Omron Healthcare, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261929Upper Arm Blood pressure monitor (BP7155D)K202228Omron Model BP7900 Blood Pressure Monitor + EKGK183215Focus TENS Therapy, Model PM710-M/-LK190693HEM-6410T-ZL Wrist Blood Pressure MonitorK182579Omron Model BP7900 Blood Pressure Monitor + EKGK182120Maxpower Relief

View all 63 devices →

Related Devices (Code: MNW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.K130856BIA / VITALITY ANALYZERIpgdx, LLCK130777INBODYBiospace Corporation LimitedK130952PRECISION ONE LIFECARE; DETECTO; DETECTOPrecision One Lifecare, Ltd.K131394TRANSTEK GLASS BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.K130311TRANSTEK BODY FAT ANALYZERGuangdong Transtek Medical Electronics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑