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510(k) Data Aggregation
K Number
K090730Device Name
AKITA JET
Manufacturer
Date Cleared
2009-11-13
(239 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
ACTIVAERO AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AKITA JET is a nebulizer system that will be used with patients for whom doctors have prescribed medication (except pentamidine) for nebulization in the home care, nursing home, subacute institution, or hospital environment.
Device Description
The AKITA JET nebulizer and the AKITA JET nebulizer handset together constitute a multi-use, electronic nebulizer system designed to aerosolize liquid medications. The system includes and features:
- An electrically powered compressor which provides an air flow to the AKITA JET ● nebulizer handset.
- . A nebulizer handset based upon the PARI LC Sprint, K060399
- Single patient, multi-use in the home setting .
- . Multiple patient, multi-use in the hospital and clinical settings
- .
- . Nebulization only during inhalation phase
- Smart Card series for defined patient breathing patterns .
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K Number
K080100Device Name
WATCHHALER
Manufacturer
Date Cleared
2008-06-30
(168 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
ACTIVAERO AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Watchhaler is a holding chamber intended to administer aerosolized medication with a Metered Dose Inhaler. For pediatric patients (3 years and older). The environment of use includes home care, nursing homes, sub-acute institutions, and hospitals
Device Description
The Watchhaler is a spacer primarily used in the pediatric population for the inhalation of approved MDIs for the therapy of the upper and lower respiratory system. The design of the device is held in the shape of a colored toy animal to address its users, the children. The device consists of a balloon which is enclosed by a translucent housing. During inhalation the balloon collapses with the speed of deflation controlled by a mechanical valve. The fixed volume of the balloon and the low inhalation flow provided by the valve help to ensure a constant drug delivery.
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K Number
K072019Device Name
AKITA2 APIXNEB
Manufacturer
Date Cleared
2007-11-05
(105 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
ACTIVAERO AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AKITA2 APIXNEB is a nebulizer system that will be used with patients for whom doctors have prescribed medication (except pentamidine) for nebulization in the home care, nursing home, sub-acute institution, or hospital environment.
The AKITA2 APIXNEB is intended for patients 3 years and older who can coordinate breathing.
Device Description
The AKITA? APIXNEB nebulizer and the handset together constitute a single patient, multi-use, electronic nebulizer system designed to aerosolize liquid medications. The system includes and features:
- An electrically powered compressor which provides an air flow to the AKITA2 . APIXNEB nebulizer handset.
- . A nebulizer handset based upon the PARI e-Flow™, K033833, which uses piezoelectric vibration of a perforated stainless steel membrane (head) for the aerosol generation.
- . Single patient use, reusable
- Nebulization only during inhalation phase .
- . Smart Card series for defined patient breathing patterns
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