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FDA 510(k)

BODYSTAT

K-Number: K971554 · 1997-11-26

ApplicantBodystat , Ltd.
Decision Date1997-11-26
Product CodeMNW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BODYSTAT is the device name listed in this FDA 510(k) record. The listed applicant is Bodystat , Ltd.. It received FDA 510(k) clearance on 1997-11-26 under 510(k) number K971554. 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?

BODYSTAT is a medical device that received FDA 510(k) clearance on 1997-11-26. The listed applicant is Bodystat , Ltd.. The 510(k) number is K971554.

When did BODYSTAT receive FDA 510(k) clearance?

BODYSTAT received FDA 510(k) clearance on 1997-11-26, under 510(k) number K971554.

Who is the listed applicant for BODYSTAT?

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?

The FDA product code for BODYSTAT 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 UNITK980971BODYSTAT DUALSCAN 2005

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.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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