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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 K040540
Device Name MODIFICATION TO LTV 1000 VENTILATOR
Applicant
PULMONETIC SYSTEMS, INC.
17400 MEDINA RD.
SUITE 100
MINNEAPOLIS,  MN  55447
Applicant Contact ROBERT C SAMEC
Correspondent
PULMONETIC SYSTEMS, INC.
17400 MEDINA RD.
SUITE 100
MINNEAPOLIS,  MN  55447
Correspondent Contact ROBERT C SAMEC
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/02/2004
Decision Date 04/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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