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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K896536
Device Name PHARMATRONICS NEBULIZER
Applicant
DIVERSATRONICS, INC.
620 PKWY.
BROOMALL,  PA  19008
Applicant Contact WILFRED KLEIN
Correspondent
DIVERSATRONICS, INC.
620 PKWY.
BROOMALL,  PA  19008
Correspondent Contact WILFRED KLEIN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/15/1989
Decision Date 07/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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