SPO2 FINGER PROBES

Oximeter

MEDICAL CABLES, INC.

The following data is part of a premarket notification filed by Medical Cables, Inc. with the FDA for Spo2 Finger Probes.

Pre-market Notification Details

Device IDK973970
510k NumberK973970
Device Name:SPO2 FINGER PROBES
ClassificationOximeter
Applicant MEDICAL CABLES, INC. 1340 LOGAN AVE. Costa Mesa,  CA  92626
ContactChristopher J Fontana
CorrespondentChristopher J Fontana
MEDICAL CABLES, INC. 1340 LOGAN AVE. Costa Mesa,  CA  92626
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-17
Decision Date1998-10-06

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