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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 K940802
Device Name ZIPPREP ELECTRODE
Applicant
Aspect Medical Systems, Inc.
770 Cochituate Rd.
Framingham,  MA  01710
Applicant Contact CHRISTINE MORGIDA
Correspondent
Aspect Medical Systems, Inc.
770 Cochituate Rd.
Framingham,  MA  01710
Correspondent Contact CHRISTINE MORGIDA
Regulation Number870.2360
Classification Product Code
DRX  
Date Received02/22/1994
Decision Date 06/22/1994
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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