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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 K051767
Device Name LTV 1000 VENTILATOR
Applicant
PULMONETIC SYSTEMS, INC.
17400 MEDINA ROAD
SUITE 100
MINNEAPOLIS,  MN  55447
Applicant Contact ROBERT C SAMEC
Correspondent
PULMONETIC SYSTEMS, INC.
17400 MEDINA ROAD
SUITE 100
MINNEAPOLIS,  MN  55447
Correspondent Contact ROBERT C SAMEC
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/30/2005
Decision Date 07/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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