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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 K103700
Device Name ESSENTIAL MRI PATIENT MONITOR
Applicant
INVIVO CORPORATION
12151 RESEARCH PKWY
ORLANDO,  FL  32826
Applicant Contact RUSTY KELLY
Correspondent
INVIVO CORPORATION
12151 RESEARCH PKWY
ORLANDO,  FL  32826
Correspondent Contact RUSTY KELLY
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/20/2010
Decision Date 03/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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