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510(k) Data Aggregation
K Number
K964384Device Name
MODEL D-290P ADMINISTRATION SET
Manufacturer
Date Cleared
1997-01-27
(84 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
PATIENT SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Model D-290P Check Valve administration set is targeted for use with those applications where a piggyback infusion is specified. The Model D-290P set is used in conjunction with a commercially available secondary infusion line inserted in the upper Y-Site and with the Invacare Model 1200 pump.
Device Description
The Model D-290P is an administration set that incorporates standard, off-the-shelf, h.V. set components (including a check valve), Medical Grade PVC tubing and a non-fluid path pumping cartridge.
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K Number
K961263Device Name
MODEL 1200 ABMULATORY INFUSION PUMP
Manufacturer
Date Cleared
1996-08-23
(143 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
PATIENT SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PSI Model 1200 ambulatory infusion pump is a multifunction pump designed to manage a wide variety of intravenous fluid profiles.
Device Description
The PSI Model 1200 is a small portable ambulatory infusion pump intended for hospital, clinic and home care use. It uses dedicated disposables and related accessories.
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