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510(k) Data Aggregation
K Number
K020424Device Name
V SET
Manufacturer
Date Cleared
2003-08-29
(567 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
HENNIG ENTERPRISES EUROPE S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The V Set is suitable for intravenous infusion of drug solutions and fluids and has been designed to connect multiple infusion lines, functioning in the administration of intravenous fluids from a number of sources into one cannula.
Device Description
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K Number
K020421Device Name
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
Manufacturer
Date Cleared
2003-04-29
(446 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
HENNIG ENTERPRISES EUROPE S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Go Medical Patient Controlled Analgesia Devices, if properly used, are intended to provide a safe and effective means of delivering various analgesic medications to in-patients and out-patients, on both an acute and/or chronic basis. This can be peformed through intravenous (IV) and epidural routes of administration. The device will be available only by prescription and will carry the following legend: "Caution : Federal Law restricts this device to sale by or on the order of a physician". (21 CFR 801.109(b)(1))
Device Description
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