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FDA 510(k)

KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530

K-Number: K081587 · 2008-10-24

ApplicantKrell Precision (Yang Zhou) Co., Ltd.
Decision Date2008-10-24
Product CodeMNW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 is the device name listed in this FDA 510(k) record. The listed applicant is Krell Precision (Yang Zhou) Co., Ltd.. It received FDA 510(k) clearance on 2008-10-24 under 510(k) number K081587. 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 KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530?

KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 is a medical device that received FDA 510(k) clearance on 2008-10-24. The listed applicant is Krell Precision (Yang Zhou) Co., Ltd.. The 510(k) number is K081587.

When did KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 receive FDA 510(k) clearance?

KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 received FDA 510(k) clearance on 2008-10-24, under 510(k) number K081587.

Who is the listed applicant for KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530?

The FDA 510(k) record lists Krell Precision (Yang Zhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530?

The FDA product code for KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 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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