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)

QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT

K-Number: K082255 · 2011-02-07

ApplicantBodystat , Ltd.
Decision Date2011-02-07
Product CodeMNW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Bodystat , Ltd.. It received FDA 510(k) clearance on 2011-02-07 under 510(k) number K082255. 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 QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT?

QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT is a medical device that received FDA 510(k) clearance on 2011-02-07. The listed applicant is Bodystat , Ltd.. The 510(k) number is K082255.

When did QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT receive FDA 510(k) clearance?

QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT received FDA 510(k) clearance on 2011-02-07, under 510(k) number K082255.

Who is the listed applicant for QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT?

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

What is the FDA product code for QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT?

The FDA product code for QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT 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 Bodystat , Ltd. 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.

K082254MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNITK082253BODYSTAT 1500 BODY COMPOSITION MONITORING UNITK002835BODYSTATK994242BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNITK980971BODYSTAT DUALSCAN 2005K971554BODYSTAT

View all 8 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.

↑