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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Blood-Pressure
510(k) Number K951226
Device Name VITALMAX 4000/MINIPACK 3100/3000
Applicant
Pace Tech, Inc.
510 Garden Ave. N.
Clearwater,  FL  33755
Applicant Contact ILHAN M BILGUTAY
Correspondent
Pace Tech, Inc.
510 Garden Ave. N.
Clearwater,  FL  33755
Correspondent Contact ILHAN M BILGUTAY
Regulation Number870.1110
Classification Product Code
DSK  
Date Received03/20/1995
Decision Date 11/21/1996
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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