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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K945138
Device Name OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS
Applicant
Invivo Research, Inc.
12601 Research Pkwy.
Orlando,  FL  32826
Applicant Contact FRANCIS X CASEY
Correspondent
Invivo Research, Inc.
12601 Research Pkwy.
Orlando,  FL  32826
Correspondent Contact FRANCIS X CASEY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/20/1994
Decision Date 11/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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