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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 K120052
Device Name CVINSIGHT
Applicant
Intelomed, Inc.
4284 Lampl Ln
Allison Park,  PA  15101
Applicant Contact JAN BERKOW
Correspondent
Intelomed, Inc.
4284 Lampl Ln
Allison Park,  PA  15101
Correspondent Contact JAN BERKOW
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
JOM  
Date Received01/06/2012
Decision Date 09/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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