FDA 510(k) Application Details - K952249

Device Classification Name Nebulizer (Direct Patient Interface)

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510(K) Number K952249
Device Name Nebulizer (Direct Patient Interface)
Applicant DEVILBISS HEALTH CARE, INC.
1200 EAST MAIN ST.
P.O.BOX 635
SOMERSET, PA 15501-0635 US
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Contact FRANK CLEMENTI
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Regulation Number 868.5630

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Classification Product Code CAF
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Date Received 05/15/1995
Decision Date 01/30/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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