CCO SYSTEM MODEL SP1467,SP5567,SP6267

Probe, Thermodilution

SPECTRAMED, INC.

The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Cco System Model Sp1467,sp5567,sp6267.

Pre-market Notification Details

Device IDK892941
510k NumberK892941
Device Name:CCO SYSTEM MODEL SP1467,SP5567,SP6267
ClassificationProbe, Thermodilution
Applicant SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
ContactRobert Leavitt
CorrespondentRobert Leavitt
SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
Product CodeKRB  
CFR Regulation Number870.1915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-21
Decision Date1989-11-06

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