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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K925295
Device Name EXACTA-SPEZIAL
Applicant
Rudolf Riester GmbH & Co. KG
Postfach 35
Bruckstrabe 31
D-72417 Jungingen,  DE
Applicant Contact KARLHEINZ RIESTER
Correspondent
Rudolf Riester GmbH & Co. KG
Postfach 35
Bruckstrabe 31
D-72417 Jungingen,  DE
Correspondent Contact KARLHEINZ RIESTER
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/21/1992
Decision Date 03/25/1994
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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