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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 K113054
Device Name EQUIVITAL
Applicant
Hidalgo Limited
Unit F Buckinghamway Business Park
Anderson Rd., Swavesey
Cambridge,  GB CB24 4UQ
Applicant Contact EKTA SOOD
Correspondent
Hidalgo Limited
Unit F Buckinghamway Business Park
Anderson Rd., Swavesey
Cambridge,  GB CB24 4UQ
Correspondent Contact EKTA SOOD
Regulation Number870.1025
Classification Product Code
MHX  
Date Received10/13/2011
Decision Date 02/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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