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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 K981371
Device Name LTV 1000 VENTILATOR
Applicant
PULMONETIC SYSTEMS, INC.
930 S. MT. VERNON AVE.
SUITE 100
COLTON,  CA  92324
Applicant Contact DOUGLAS DEVRIES
Correspondent
PULMONETIC SYSTEMS, INC.
930 S. MT. VERNON AVE.
SUITE 100
COLTON,  CA  92324
Correspondent Contact DOUGLAS DEVRIES
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/16/1998
Decision Date 10/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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