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510(k) Data Aggregation
K Number
K990506Device Name
MABIS NB-02 ULTRASONIC NEBULIZER
Manufacturer
MABIS HEALTHCARE, INC.
Date Cleared
1999-03-11
(22 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
MABIS HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MABIS NB-02 is an ultrasonic nebulizer intended for use in the treatment of asthma, COPD, and other respiratory ailments in which an aerosolized medication is required during therapy. It may be necessary to perform respiratory therapy at anytime and anywhere the patient needs it. The MABIS NB-02 nebulizer is not intended for use with Pentamidine. It is intended for single patient use.
Device Description
MABIS NB-02 Ultrasonic Nebulizer
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