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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K860827
Device Name EM STRESS ELECTRODE
Applicant
Electromed Intl., Ltd.
34 Bear Hill Rd.
Waltham,  MA  02154
Applicant Contact MEGAN J MACAULEY
Correspondent
Electromed Intl., Ltd.
34 Bear Hill Rd.
Waltham,  MA  02154
Correspondent Contact MEGAN J MACAULEY
Regulation Number870.2360
Classification Product Code
DRX  
Date Received03/05/1986
Decision Date 05/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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