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510(k) Data Aggregation
K Number
K023973Device Name
AUTOMED 3200 INFUSION PUMP
Manufacturer
Date Cleared
2003-02-27
(87 days)
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
HELP TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AutoMed 3200 ambulatory infusion pump with integrated administration set is intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites. The AutoMed 3200 infusion pump is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
Device Description
The AutoMed 3200 infusion pump with integrated administration set and drug reservoir is a rotary peristaltic pump. Associated dedicated administration set, AM 330, and accessories are part of the overall system. The system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
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K Number
K023863Device Name
AUTOMED 3000 INFUSION PUMP
Manufacturer
Date Cleared
2003-02-07
(79 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
HELP TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AutoMed 3000 ambulatory infusion pump with integrated administration set/drug reservoir is intended for general infusion use. Routes of infusion include intravenous. percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
Device Description
The AutoMed 3000 infusion pump with integrated administration set and drug reservoir is a rotary peristaltic pump. Associated dedicated administration set AM 330 and accessories are part of the overall system. The system is suitable for use as ambulatory devices and is intended for use in the hospital, home environment or alternative care sites.
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K Number
K023491Device Name
AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
Manufacturer
Date Cleared
2002-12-13
(57 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
HELP TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AutoMed 3300 and 3400 ambulatory infusion pumps and dedicated administration sets and accessories are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intraoperative (soft tissue / body cavity) sites. The AutoMed systems are also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
Device Description
The AutoMed Systems presented in this product notification include the AM 3300 and AM 3400 rotary peristaltic pumps and associated dedicated administration sets (AM 320, AM 330 and AM 340) and accessories. The systems are suitable for use as ambulatory devices and that are intended for use in the hospital, home environment or alternative care sites.
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