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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K010608
Device Name MODIFICATION TO LAP TOP VENTILATOR (LTV)
Applicant
PULMONETIC SYSTEMS, INC.
930 SOUTH MT. VERNON AVE.,
SUITE 100
COLTON,  CA  92324 -3928
Applicant Contact DARRYL SHELBY
Correspondent
PULMONETIC SYSTEMS, INC.
930 SOUTH MT. VERNON AVE.,
SUITE 100
COLTON,  CA  92324 -3928
Correspondent Contact DARRYL SHELBY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/01/2001
Decision Date 03/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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