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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 K070594
Device Name PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
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 Received03/02/2007
Decision Date 08/01/2007
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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