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510(k) Data Aggregation
K Number
K972657Device Name
ULTRAMIST 2000
Manufacturer
Date Cleared
1998-02-02
(202 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
TEXAS MEDICAL INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ULTRAMIST 2000 is an aerosol therapy apparatus which is designed for the treatment of respiratory disorders. It is designed for home use by patients ranging in age from toddlers to adult to geriatric. Normal usage is based on prescribed medication and is typically used three to four times a day.
Through the use of a separate nebulizer, it produces a simple means for delivering medication in a mist form which is inhaled into the bronchial tree for therapeutic reasons. A treatment of 3 - 3.5 ml can be completed in less than 10 minutes and produces microscopic particles which allow for deeper penetration.
The device is to be used only on the order of a licensed physician.
Device Description
The ULTRAMIST 2000 is an aerosol therapy apparatus.
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