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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 K873168
Device Name SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS
Applicant
Spectramed, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Applicant Contact ROBERT L LEAVITT
Correspondent
Spectramed, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Correspondent Contact ROBERT L LEAVITT
Regulation Number870.2850
Classification Product Code
DRS  
Date Received08/11/1987
Decision Date 01/12/1988
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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