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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 K945099
Device Name PARAMETERS MONITORES
Applicant
Ivy Biomedical Systems, Inc.
11 Business Park Dr.
Branford,  CT  06405
Applicant Contact DICK LISTRO
Correspondent
Ivy Biomedical Systems, Inc.
11 Business Park Dr.
Branford,  CT  06405
Correspondent Contact DICK LISTRO
Regulation Number870.1025
Classification Product Code
MHX  
Date Received10/18/1994
Decision Date 07/13/1995
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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