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FDA 510(k)

PHYSIOFLOW ENDURO

K-Number: K103283 · 2010-12-03

ApplicantVasocom, Inc.
Decision Date2010-12-03
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHYSIOFLOW ENDURO is the device name listed in this FDA 510(k) record. The listed applicant is Vasocom, Inc.. It received FDA 510(k) clearance on 2010-12-03 under 510(k) number K103283. 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 PHYSIOFLOW ENDURO?

PHYSIOFLOW ENDURO is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is Vasocom, Inc.. The 510(k) number is K103283.

When did PHYSIOFLOW ENDURO receive FDA 510(k) clearance?

PHYSIOFLOW ENDURO received FDA 510(k) clearance on 2010-12-03, under 510(k) number K103283.

Who is the listed applicant for PHYSIOFLOW ENDURO?

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

What is the FDA product code for PHYSIOFLOW ENDURO?

The FDA product code for PHYSIOFLOW ENDURO is DSB.

Related Clinical Trials

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.

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Other records listing Vasocom, Inc. 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.

K060387PHYSIOFLOW SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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