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510(k) Data Aggregation
K Number
K031982Device Name
BIRDSONG LEVERHALER, MODEL LH-1000
Manufacturer
Date Cleared
2004-04-02
(281 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
BIRDSONG MEDICAL DEVICES INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LeverHaler Spacer is a spacer device that is designed to effectively deliver respirable medical aerosols produced by most MDI's to a patient during inhalation. This product is intended for use in the treatment of lung disease. The device has been designed for use by all patients who have been prescribed MDI treatment by their physician. It is intended for use in both the hospital and homecare environments.
Device Description
The LeverHaler Spacer (Spacer) is an injection molded polycarbonate spacer device intended for use with FDA approved metered dose inhalers (MDI's). The MDI canister fits through a slot in a lever located on the top of the spacer. Activation of the MDI canister can be done by manually pressing down on the MDI (typical activation), or the MDI may be actuated by depressing the Lever Actuator down towards the top of the spacer body. The device is made from polycarbonate injection molded plastic and is designed to be used with FDA approved MDI drugs for treatment of lung disease. When not in use, up to two MDI canisters can be stored inside of the LeverHaler Chamber. The product is sold non-sterile, and is a single-patient device intended to be used for up to one year. This device does not generate aerosols. Its purpose is to provide an effective mixing chamber for the aerosols produced by a metered dose inhaler to assure proper concentration for inhalation by the patient. This is a prescription device. The device has no detection capabilities. It is mechanical and has no alarm functions or capabilities. There is no software integrated or used in conjunction with this device.
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