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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K040581
Device Name MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM
Applicant
VITEL NET
8201 GREENSBORO DR.
SUITE 820
MCLEAN,  VA  22102
Applicant Contact ALLEN IZADPANAH
Correspondent
VITEL NET
8201 GREENSBORO DR.
SUITE 820
MCLEAN,  VA  22102
Correspondent Contact ALLEN IZADPANAH
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/04/2004
Decision Date 05/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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