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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number K012712
Device Name NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
Applicant
NORAV MEDICAL LTD.
12505 58TH AVE. N.
PLYMOUTH,  MN  55442
Applicant Contact STEVE SPRINGROSE
Correspondent
NORAV MEDICAL LTD.
12505 58TH AVE. N.
PLYMOUTH,  MN  55442
Correspondent Contact STEVE SPRINGROSE
Regulation Number870.2800
Classification Product Code
MLO  
Date Received08/14/2001
Decision Date 05/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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