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FDA 510(k)

FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01

K-Number: K003582 · 2000-12-05

ApplicantFluidsense Corp.
Decision Date2000-12-05
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 is the device name listed in this FDA 510(k) record. The listed applicant is Fluidsense Corp.. It received FDA 510(k) clearance on 2000-12-05 under 510(k) number K003582. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01?

FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 is a medical device that received FDA 510(k) clearance on 2000-12-05. The listed applicant is Fluidsense Corp.. The 510(k) number is K003582.

When did FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 receive FDA 510(k) clearance?

FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 received FDA 510(k) clearance on 2000-12-05, under 510(k) number K003582.

Who is the listed applicant for FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01?

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

What is the FDA product code for FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01?

The FDA product code for FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01 is FRN.

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 Fluidsense Corp. 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.

K982170FLUIDSENSE FLUID DELIVERY SYSTEM

Related Devices (Code: FRN)

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.

K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D CorpK252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare CorporationK251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare CorporationK242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed CorporationK243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, 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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