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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 Rd.
Suite 100
Plymouth,  MN  55447
Applicant Contact ROBERT C SAMEC
Correspondent
Pulmonetic Systems, Inc.
17400 Medina Rd.
Suite 100
Plymouth,  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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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