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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K880917
Device Name LYTENING 5
Applicant
Amdev, Inc.
35 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact ARTHUR G SCHNEIDER
Correspondent
Amdev, Inc.
35 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact ARTHUR G SCHNEIDER
Regulation Number862.1665
Classification Product Code
JGS  
Date Received03/03/1988
Decision Date 05/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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