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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K062068
Device Name INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0
Applicant
Intelwave, LLC
1090 King Georges Post Rd.
Suite 1004
Edison,  NJ  08837
Applicant Contact ALEXANDER RIFTINE
Correspondent
Intelwave, LLC
1090 King Georges Post Rd.
Suite 1004
Edison,  NJ  08837
Correspondent Contact ALEXANDER RIFTINE
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/21/2006
Decision Date 10/27/2006
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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