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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, Physiological Signal, Radiofrequency
510(k) Number K091021
Device Name MODIFICATION TO MEDICOMPASS CONNECT
Applicant
Imetrikus, Inc.
2141 Landings Dr.
Mountain View,  CA  94043
Applicant Contact MICHAEL ACOSTA
Correspondent
Imetrikus, Inc.
2141 Landings Dr.
Mountain View,  CA  94043
Correspondent Contact MICHAEL ACOSTA
Regulation Number870.2910
Classification Product Code
DRG  
Date Received04/09/2009
Decision Date 07/15/2009
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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