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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K053149
Device Name SPIRO-BALL
Applicant
LEVENTON, S.A.
C/NEWTON 18-24, POLIGONO
INDUSTRIAL SESROVIRES, SANT
ESTEVE SESROVIRES, BARCELONA,  ES 08635
Applicant Contact ORIOL VERNIS
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number868.5690
Classification Product Code
BWF  
Date Received11/10/2005
Decision Date 12/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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