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FDA 510(k)

MODEL 404A I.V. INFUSION PUMP ANALYZER

K-Number: K897096 · 1990-03-15

ApplicantDynatech/Nevada, Inc.
Decision Date1990-03-15
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL 404A I.V. INFUSION PUMP ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech/Nevada, Inc.. It received FDA 510(k) clearance on 1990-03-15 under 510(k) number K897096. 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 MODEL 404A I.V. INFUSION PUMP ANALYZER?

MODEL 404A I.V. INFUSION PUMP ANALYZER is a medical device that received FDA 510(k) clearance on 1990-03-15. The listed applicant is Dynatech/Nevada, Inc.. The 510(k) number is K897096.

When did MODEL 404A I.V. INFUSION PUMP ANALYZER receive FDA 510(k) clearance?

MODEL 404A I.V. INFUSION PUMP ANALYZER received FDA 510(k) clearance on 1990-03-15, under 510(k) number K897096.

Who is the listed applicant for MODEL 404A I.V. INFUSION PUMP ANALYZER?

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

What is the FDA product code for MODEL 404A I.V. INFUSION PUMP ANALYZER?

The FDA product code for MODEL 404A I.V. INFUSION PUMP ANALYZER 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 Dynatech/Nevada, 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.

K942546CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZERK935817MEDSIM 300 PATIENT SIMULATORK934254IMPULSE 3000 DEFIBRILLATOR ANALYZERK897074MODEL 215M PATIENT SIMULATORK897029MODEL ECG100 SIMULATOR

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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