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FDA 510(k)

BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18)

K-Number: K851415 · 1985-07-08

ApplicantMedi-Sport Testing, Inc.
Decision Date1985-07-08
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18) is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Sport Testing, Inc.. It received FDA 510(k) clearance on 1985-07-08 under 510(k) number K851415. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18)?

BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18) is a medical device that received FDA 510(k) clearance on 1985-07-08. The listed applicant is Medi-Sport Testing, Inc.. The 510(k) number is K851415.

When did BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18) receive FDA 510(k) clearance?

BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18) received FDA 510(k) clearance on 1985-07-08, under 510(k) number K851415.

Who is the listed applicant for BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18)?

The FDA 510(k) record lists Medi-Sport Testing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18)?

The FDA product code for BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18) is DSB.

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Related Devices (Code: DSB)

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.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.

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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