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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Thermodilution
510(k) Number K812800
Device Name FLOW-DIRECTED THERMODILUTION CATHETER
Applicant
Sorensen Research
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Sorensen Research
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1915
Classification Product Code
KRB  
Date Received10/06/1981
Decision Date 10/20/1981
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
Recalls CDRH Recalls
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