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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 K913263
Device Name VITALMAX 830 SERIES
Applicant
Pace Tech, Inc.
510 Garden Ave. N.
Clearwater,  FL  33755
Applicant Contact MARY J BILGUTAY
Correspondent
Pace Tech, Inc.
510 Garden Ave. N.
Clearwater,  FL  33755
Correspondent Contact MARY J BILGUTAY
Regulation Number870.1025
Classification Product Code
MHX  
Date Received07/23/1991
Decision Date 10/10/1991
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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