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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Air, Portable
510(k) Number K931015
Device Name DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER
Applicant
DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET,  PA  15501 -0635
Applicant Contact RICHARD J KOCINSKI
Correspondent
DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET,  PA  15501 -0635
Correspondent Contact RICHARD J KOCINSKI
Regulation Number868.6250
Classification Product Code
BTI  
Date Received02/26/1993
Decision Date 09/30/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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