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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(With Arrhythmia Detection Or Alarms)
510(k) Number K973474
Device Name WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS
Applicant
Witt Biomedical Corporation
295 N. Dr.,
Suite H
Melbourne,  FL  32934
Applicant Contact LORRAINE R FREDES
Correspondent
Witt Biomedical Corporation
295 N. Dr.,
Suite H
Melbourne,  FL  32934
Correspondent Contact LORRAINE R FREDES
Regulation Number870.1025
Classification Product Code
MHX  
Date Received09/12/1997
Decision Date 03/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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