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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient (without arrhythmia detection or alarms)
510(k) Number K002030
Device Name OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
Applicant
INVIVO RESEARCH, INC.
12601 RESEARCH PKWY.
ORLANDO,  FL  32826
Applicant Contact FRANCIS CASEY
Correspondent
INVIVO RESEARCH, INC.
12601 RESEARCH PKWY.
ORLANDO,  FL  32826
Correspondent Contact FRANCIS CASEY
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/03/2000
Decision Date 09/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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