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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K942072
Device Name MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND
Applicant
Mabis Healthcare, Inc.
28401 N. Ballard Dr.
Unit H
Lake Forest,  IL  60045
Applicant Contact MICHAEL A MAZZA
Correspondent
Mabis Healthcare, Inc.
28401 N. Ballard Dr.
Unit H
Lake Forest,  IL  60045
Correspondent Contact MICHAEL A MAZZA
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/29/1994
Decision Date 05/10/1995
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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