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FDA 510(k)

BODYSTAT DUALSCAN 2005

K-Number: K980971 · 1998-06-11

ApplicantBodystat , Ltd.
Decision Date1998-06-11
Product CodeMNW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BODYSTAT DUALSCAN 2005 is the device name listed in this FDA 510(k) record. The listed applicant is Bodystat , Ltd.. It received FDA 510(k) clearance on 1998-06-11 under 510(k) number K980971. 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 BODYSTAT DUALSCAN 2005?

BODYSTAT DUALSCAN 2005 is a medical device that received FDA 510(k) clearance on 1998-06-11. The listed applicant is Bodystat , Ltd.. The 510(k) number is K980971.

When did BODYSTAT DUALSCAN 2005 receive FDA 510(k) clearance?

BODYSTAT DUALSCAN 2005 received FDA 510(k) clearance on 1998-06-11, under 510(k) number K980971.

Who is the listed applicant for BODYSTAT DUALSCAN 2005?

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 BODYSTAT DUALSCAN 2005?

The FDA product code for BODYSTAT DUALSCAN 2005 is MNW.

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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 UNITK082255QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNITK082253BODYSTAT 1500 BODY COMPOSITION MONITORING UNITK002835BODYSTATK994242BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNITK971554BODYSTAT

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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.K130777INBODYBiospace Corporation LimitedK130856BIA / VITALITY ANALYZERIpgdx, LLCK130952PRECISION 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.

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