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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 K010751
Device Name BPFONE, MODEL UA 767IT
Applicant
Medical Monitors Pty Limited
166 Belmore Rd.; Suite 14
Randwick Nsw,  AU 2031
Applicant Contact HARRY L PLATT
Correspondent
Medical Monitors Pty Limited
166 Belmore Rd.; Suite 14
Randwick Nsw,  AU 2031
Correspondent Contact HARRY L PLATT
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/13/2001
Decision Date 06/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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