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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Miniature Pressure
510(k) Number K060125
Device Name SONIC PALPOMETER
Applicant
Palpometer Systems, Inc.
R Hut Mckenzie Ave.
P.O. Box 3075 Stn Csc
Victoria, British Columbia,  CA V8W 3W2
Applicant Contact LINDSAY ROACH
Correspondent
Intertek Testing Services
70 Codman Hill Rd.
Boxborough,  MA  01719
Correspondent Contact DANIEL W LEHTONEN
Regulation Number890.1615
Classification Product Code
IKE  
Date Received01/18/2006
Decision Date 03/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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