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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K082626
Device Name PAM 3000
Applicant
Wireless 2000 RF & Uwb Technologies , Ltd.
2421 Alpha Ave.
Burnaby, Bc,  CA V5C5L2
Applicant Contact EFRAIM GAVRILOVICH
Correspondent
Wireless 2000 RF & Uwb Technologies , Ltd.
2421 Alpha Ave.
Burnaby, Bc,  CA V5C5L2
Correspondent Contact EFRAIM GAVRILOVICH
Regulation Number870.2300
Classification Product Code
DRT  
Date Received09/09/2008
Decision Date 01/16/2009
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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