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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transducer, pressure, catheter tip
510(k) Number K880830
Device Name SENTORR ARTERIAL PRESSURE SENSOR
Applicant
OHMEDA MEDICAL
2007 PAN AM CIRCLE
TAMPA,  FL  33702
Applicant Contact JILL PHILLIPS
Correspondent
OHMEDA MEDICAL
2007 PAN AM CIRCLE
TAMPA,  FL  33702
Correspondent Contact JILL PHILLIPS
Regulation Number870.2870
Classification Product Code
DXO  
Date Received03/01/1988
Decision Date 08/12/1988
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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