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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 K885177
Device Name PHYSIOGARD SM 785
Applicant
Adam
34, Rue De L'Industrie
67160 Wissembourg
France,  FR
Applicant Contact GOEHRY
Correspondent
Adam
34, Rue De L'Industrie
67160 Wissembourg
France,  FR
Correspondent Contact GOEHRY
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/13/1988
Decision Date 03/31/1989
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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