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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K042981
Device Name HYPERQ SYSTEM
Applicant
Biological Signal Processing, Ltd.
20 Hata'As St.
Kfar Saba,  IL 44425
Applicant Contact ARAVA HACOHEN
Correspondent
Biological Signal Processing, Ltd.
20 Hata'As St.
Kfar Saba,  IL 44425
Correspondent Contact ARAVA HACOHEN
Regulation Number870.2300
Classification Product Code
MWI  
Date Received10/29/2004
Decision Date 03/10/2005
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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