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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 K002881
Device Name VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000
Applicant
PULMONETIC SYSTEMS, INC.
930 SOUTH MT. VERNON AVE.,
SUITE 100
COLTON,  CA  92324 -3928
Applicant Contact ROBERT HANKINS
Correspondent
PULMONETIC SYSTEMS, INC.
930 SOUTH MT. VERNON AVE.,
SUITE 100
COLTON,  CA  92324 -3928
Correspondent Contact ROBERT HANKINS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/15/2000
Decision Date 10/11/2000
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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