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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 K902453
Device Name OSCILLOMETRIC PULSE DETECTION DEVICE
Applicant
Thomas J. Fogarty, M.D.
3270 Alpine Rd.
Portola Valley,  CA  94028
Applicant Contact FOGARTY, MD
Correspondent
Thomas J. Fogarty, M.D.
3270 Alpine Rd.
Portola Valley,  CA  94028
Correspondent Contact FOGARTY, MD
Regulation Number870.2850
Classification Product Code
DRS  
Date Received06/01/1990
Decision Date 08/23/1990
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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