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FDA 510(k)

ISSYS DRUG FLOW MONITOR

K-Number: K050783 · 2006-02-22

ApplicantIntegrated Sensing Systems, Inc.
Decision Date2006-02-22
Product CodeFLN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ISSYS DRUG FLOW MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Sensing Systems, Inc.. It received FDA 510(k) clearance on 2006-02-22 under 510(k) number K050783. The device is classified under product code FLN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISSYS DRUG FLOW MONITOR?

ISSYS DRUG FLOW MONITOR is a medical device that received FDA 510(k) clearance on 2006-02-22. The listed applicant is Integrated Sensing Systems, Inc.. The 510(k) number is K050783.

When did ISSYS DRUG FLOW MONITOR receive FDA 510(k) clearance?

ISSYS DRUG FLOW MONITOR received FDA 510(k) clearance on 2006-02-22, under 510(k) number K050783.

Who is the listed applicant for ISSYS DRUG FLOW MONITOR?

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

What is the FDA product code for ISSYS DRUG FLOW MONITOR?

The FDA product code for ISSYS DRUG FLOW MONITOR is FLN.

Related Clinical Trials

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Related Devices (Code: FLN)

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.

K172242DripAssist PlusShift Labs, Inc.K080704LOW FLUID ALARMEm-Tec GmbHK060123LEVELERT II FLUID LEVEL SENSORSmith & Nephew, Inc.K030136DRIP ALERTDrip Alert, Inc.K022248STRYKER L3 HYDROLERTStryker EndoscopyK013121MT ALERT INFUSION MONITORSierra Biosearch, 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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