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FDA 510(k)

BODY FAT ANALYZER, MODEL HBF-306

K-Number: K011652 · 2001-11-07

ApplicantOmron Healthcare, Inc.
Decision Date2001-11-07
Product CodeMNW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BODY FAT ANALYZER, MODEL HBF-306 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 2001-11-07 under 510(k) number K011652. 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 BODY FAT ANALYZER, MODEL HBF-306?

BODY FAT ANALYZER, MODEL HBF-306 is a medical device that received FDA 510(k) clearance on 2001-11-07. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K011652.

When did BODY FAT ANALYZER, MODEL HBF-306 receive FDA 510(k) clearance?

BODY FAT ANALYZER, MODEL HBF-306 received FDA 510(k) clearance on 2001-11-07, under 510(k) number K011652.

Who is the listed applicant for BODY FAT ANALYZER, MODEL HBF-306?

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 BODY FAT ANALYZER, MODEL HBF-306?

The FDA product code for BODY FAT ANALYZER, MODEL HBF-306 is MNW.

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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.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.

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