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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K103077
Device Name ECG PEN
Applicant
MERIDIAN DYNAMICS BIOMEDICAL, INC
2904 N. BOLDT DRIVE
FLAGSTAFF,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
MERIDIAN DYNAMICS BIOMEDICAL, INC
2904 N. BOLDT DRIVE
FLAGSTAFF,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/18/2010
Decision Date 07/13/2011
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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