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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 K013311
Device Name MODIFICATION TO: POCKETVIEW ECG SOFTWARE
Applicant
MICROMEDICAL INDUSTRIES, LTD.
11 TECHNOLOGY DR.
LABRADOR QUEENSLAND,  AU 4215
Applicant Contact STEPHEN CRESSWELL
Correspondent
MICROMEDICAL INDUSTRIES, LTD.
11 TECHNOLOGY DR.
LABRADOR QUEENSLAND,  AU 4215
Correspondent Contact STEPHEN CRESSWELL
Regulation Number870.1025
Classification Product Code
MHX  
Date Received10/04/2001
Decision Date 01/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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