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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 K041491
Device Name ZEWA MFM-007 BLOOD PRESSURE MONITOR
Applicant
Zewa, Inc.
3537 NW 115th Ave.
Miami,  FL  33178
Applicant Contact THOMAS ZEINDLER
Correspondent
Zewa, Inc.
3537 NW 115th Ave.
Miami,  FL  33178
Correspondent Contact THOMAS ZEINDLER
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/04/2004
Decision Date 09/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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