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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 K984056
Device Name LTV 1000
Applicant
PULMONETIC SYSTEMS, INC.
930 S. MT. VERNON AVE.
SUITE 100
COLTON,  CA  92324
Applicant Contact DOUGLAS F DEVRIES
Correspondent
PULMONETIC SYSTEMS, INC.
930 S. MT. VERNON AVE.
SUITE 100
COLTON,  CA  92324
Correspondent Contact DOUGLAS F DEVRIES
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/13/1998
Decision Date 04/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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