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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(With Arrhythmia Detection Or Alarms)
510(k) Number K061993
Device Name EQUIVITAL, MODEL EQ-01
Applicant
Hidalgo Limited
Stable Block At The Grange
20 Market St.
Swavesey Cambridge,  GB CB4-5QG
Applicant Contact JUSTIN PISANI
Correspondent
Hidalgo Limited
Stable Block At The Grange
20 Market St.
Swavesey Cambridge,  GB CB4-5QG
Correspondent Contact JUSTIN PISANI
Regulation Number870.1025
Classification Product Code
MHX  
Date Received07/14/2006
Decision Date 11/03/2006
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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