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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K061977
Device Name PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES
Applicant
Pinmed, Inc.
245 Melwood Ave., #501
Pittsburg,  PA  15213
Applicant Contact VLADIMIR SHUSTERMAN
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact NEIL E DEVINE
Regulation Number870.2920
Classification Product Code
DXH  
Date Received07/13/2006
Decision Date 07/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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