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FDA 510(k)

BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR

K-Number: K110645 · 2011-06-03

ApplicantSonosite,Inc.
Decision Date2011-06-03
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Sonosite,Inc.. It received FDA 510(k) clearance on 2011-06-03 under 510(k) number K110645. 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 BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR?

BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR is a medical device that received FDA 510(k) clearance on 2011-06-03. The listed applicant is Sonosite,Inc.. The 510(k) number is K110645.

When did BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR receive FDA 510(k) clearance?

BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR received FDA 510(k) clearance on 2011-06-03, under 510(k) number K110645.

Who is the listed applicant for BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR?

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

What is the FDA product code for BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR?

The FDA product code for BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR is DSB.

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Other records listing Sonosite,Inc. as applicant

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Related Devices (Code: DSB)

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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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