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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K110878
Device Name RHYTHMVIEW (TM)
Applicant
Topera, Inc.
11445 E. Via Linda
Suite 2, P.O. Box 224
Scottsdale,  AZ  85259
Applicant Contact RUCHIR SEHRA
Correspondent
Topera, Inc.
11445 E. Via Linda
Suite 2, P.O. Box 224
Scottsdale,  AZ  85259
Correspondent Contact RUCHIR SEHRA
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/30/2011
Decision Date 09/23/2011
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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