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Found 4 results
510(k) Data Aggregation
K Number
K081463Device Name
MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP
Manufacturer
Date Cleared
2009-02-06
(259 days)
Product Code
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
MEDEL S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Intended Use of the GENTLEFEED DUO BREAST PUMP is to express milk from the breast of lactating women.
Device Description
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K Number
K072494Device Name
AG-CLASSIC
Manufacturer
Date Cleared
2008-02-12
(160 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
MEDEL S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medel AG-CLASSIC Nebulization System, which includes the Medel AG-CLASSIC Compressor and the Medel Jet Nebulizer, is intended for the production of medical aerosol for respiratory disorders such as asthma, chronic obstructive pulmonary disease (COPD), bronchitis and emphysema for children or adults in the home. The Medel Jet nebulizer is a "single patient reuse" nebulizer and is to be used by one person multiple times. The use of the Medel AG-CLASSIC is for the production of medical aerosols with approved medications and requires the order of a physician for medical use. The AG-CLASSIC is not intended as a life sustaining or life-supporting device.
Device Description
The Medel AG-CLASSIC Nebulization System, which includes the Medel AG-CLASSIC Compressor and the Medel Jet Nebulizer, is intended for the production of medical aerosol for respiratory disorders such as asthma, chronic obstructive pulmonary disease (COPD), bronchitis and emphysema for children or adults in the home. The Medel Jet nebulizer is a "single patient reuse" nebulizer and is to be used by one person multiple times.
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K Number
K063103Device Name
AG-EDGE, MODEL 91200
Manufacturer
Date Cleared
2007-01-08
(90 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
MEDEL S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the AG EDGE is to convert liquid medication into a fine mist that can be drawn into the lungs to treat respiratory conditions for adult and pediatric patients who have been prescribed inhalation therapy or medication.
The AG EDGE is indicated only for use with nebulizer provided and viceversa.
The AG EDGE is transportable equipment intended for home health care use. The AG EDGE is not intended as a life sustaining or life support device.
Device Description
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K Number
K060404Device Name
AG-PLUS, MODEL 91210
Manufacturer
Date Cleared
2006-06-22
(127 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
MEDEL S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the AG PLUS is to convert liquid medication into a fine mist that can be drawn into the lungs to treat respiratory conditions for adult and pediatric patients who have been prescribed inhalation therapy or medication.
The AG PLUS compressor is to be used only with specific 510(k) cleared nebulizer whose input specifications may be met by the pressure and flow characteristics of the AG PLUS compressor. The initial nebulizer distributed with the AG PLUS compressor will be the Medel Jet Pro, the performance of which is contained in this 510(k) notification.
The AG PLUS is transportable equipment intended for home health care use. The AG PLUS is not intended as a life sustaining or life support device.
Device Description
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