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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 K073694
Device Name IVENT 2001 MRI CONDITIONAL
Applicant
Versamed Medical Systems, Inc.
3460 Pt.e Creek Ct.
Suite 102
Bonita Springs,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
Versamed Medical Systems, Inc.
3460 Pt.e Creek Ct.
Suite 102
Bonita Springs,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/31/2007
Decision Date 05/30/2008
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
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