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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Thermodilution
510(k) Number K892941
Device Name CCO SYSTEM MODEL SP1467,SP5567,SP6267
Applicant
Spectramed, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Applicant Contact ROBERT LEAVITT
Correspondent
Spectramed, Inc.
1900 Williams Dr.
Oxnard,  CA  93030
Correspondent Contact ROBERT LEAVITT
Regulation Number870.1915
Classification Product Code
KRB  
Date Received04/21/1989
Decision Date 11/06/1989
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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