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FDA 510(k)

ZOE FLUID STATUS MONITOR

K-Number: K131509 · 2013-06-28

ApplicantNoninvasive Medical Technologies, Inc.
Decision Date2013-06-28
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOE FLUID STATUS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Noninvasive Medical Technologies, Inc.. It received FDA 510(k) clearance on 2013-06-28 under 510(k) number K131509. 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 ZOE FLUID STATUS MONITOR?

ZOE FLUID STATUS MONITOR is a medical device that received FDA 510(k) clearance on 2013-06-28. The listed applicant is Noninvasive Medical Technologies, Inc.. The 510(k) number is K131509.

When did ZOE FLUID STATUS MONITOR receive FDA 510(k) clearance?

ZOE FLUID STATUS MONITOR received FDA 510(k) clearance on 2013-06-28, under 510(k) number K131509.

Who is the listed applicant for ZOE FLUID STATUS MONITOR?

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

What is the FDA product code for ZOE FLUID STATUS MONITOR?

The FDA product code for ZOE FLUID STATUS MONITOR 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 Noninvasive Medical Technologies, 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.

K112830ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)

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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