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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 K844392
Device Name CARDIOSTAT 1 ECG RECORDER
Applicant
Siemens Elema AB
135 S. La Salle St.
Chicago,  IL  60603
Applicant Contact JOSEPH R RADZIUS
Correspondent
Siemens Elema AB
135 S. La Salle St.
Chicago,  IL  60603
Correspondent Contact JOSEPH R RADZIUS
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/13/1984
Decision Date 04/11/1985
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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