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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K936051
Device Name OMNI-CENTRAL STATION MONITOR
Applicant
Invivo Research, Inc.
12601 Research Pkwy.
Orlando,  FL  32826
Applicant Contact DAVE PAGE
Correspondent
Invivo Research, Inc.
12601 Research Pkwy.
Orlando,  FL  32826
Correspondent Contact DAVE PAGE
Regulation Number870.2300
Classification Product Code
DRT  
Date Received12/20/1993
Decision Date 07/06/1994
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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