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FDA 510(k)

PREPARE HOME INFUSION PUMP

K-Number: K983634 · 1999-02-24

ApplicantMedical Infusion Technologies, Inc.
Decision Date1999-02-24
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PREPARE HOME INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Medical Infusion Technologies, Inc.. It received FDA 510(k) clearance on 1999-02-24 under 510(k) number K983634. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREPARE HOME INFUSION PUMP?

PREPARE HOME INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1999-02-24. The listed applicant is Medical Infusion Technologies, Inc.. The 510(k) number is K983634.

When did PREPARE HOME INFUSION PUMP receive FDA 510(k) clearance?

PREPARE HOME INFUSION PUMP received FDA 510(k) clearance on 1999-02-24, under 510(k) number K983634.

Who is the listed applicant for PREPARE HOME INFUSION PUMP?

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

What is the FDA product code for PREPARE HOME INFUSION PUMP?

The FDA product code for PREPARE HOME INFUSION PUMP is MEB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medical Infusion 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.

K970849ENTERAL NUTRITION 1000 ML/500ML

Related Devices (Code: MEB)

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.

K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte. , Ltd.K240624InfuLifeFirst Medical Source, LLCK242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte. , Ltd.K181360ON-Q* Pump with BolusHalyard HealthK151650SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.K131247MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEMMfs - Medical Flow Systems, Ltd.

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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