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FDA 510(k)

BODYSTAY

K-Number: K951097 · 1995-11-22

ApplicantBodystat , Ltd.
Decision Date1995-11-22
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BODYSTAY is the device name listed in this FDA 510(k) record. The listed applicant is Bodystat , Ltd.. It received FDA 510(k) clearance on 1995-11-22 under 510(k) number K951097. 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 BODYSTAY?

BODYSTAY is a medical device that received FDA 510(k) clearance on 1995-11-22. The listed applicant is Bodystat , Ltd.. The 510(k) number is K951097.

When did BODYSTAY receive FDA 510(k) clearance?

BODYSTAY received FDA 510(k) clearance on 1995-11-22, under 510(k) number K951097.

Who is the listed applicant for BODYSTAY?

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 BODYSTAY?

The FDA product code for BODYSTAY is DSB.

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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: 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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