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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K972377
Device Name RI-MEGA
Applicant
Rudolf Riester GmbH & Co. KG
Bruckstrasse 31
P.O. Box 35
Jungingen,  DE D-72417
Applicant Contact PATRICIA RIESTER FREUDENMANN
Correspondent
Rudolf Riester GmbH & Co. KG
Bruckstrasse 31
P.O. Box 35
Jungingen,  DE D-72417
Correspondent Contact PATRICIA RIESTER FREUDENMANN
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received06/26/1997
Decision Date 09/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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