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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 K831506
Device Name DISP. TRANSDUCER W/MONITORING KIT TRANS
Applicant
SORENSEN RESEARCH
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SORENSEN RESEARCH
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.2850
Classification Product Code
DRS  
Date Received05/11/1983
Decision Date 08/12/1983
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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