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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 K841960
Device Name CARDIO METRICS INVASIVE PRESSURE MONIT
Applicant
Sterile Design, Inc.
P.O. Box 12100
Oldsmar,  FL  34677
Correspondent
Sterile Design, Inc.
P.O. Box 12100
Oldsmar,  FL  34677
Regulation Number870.2850
Classification Product Code
DRS  
Date Received05/14/1984
Decision Date 11/08/1985
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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