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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transducer, blood-pressure, extravascular
510(k) Number K813464
Device Name DISPOSABLE TRANSDUCER
Applicant
SORENSEN RESEARCH
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SORENSEN RESEARCH
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.2850
Classification Product Code
DRS  
Date Received12/11/1981
Decision Date 01/07/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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