NEWOX2

Oximeter

BCI INTL., INC.

The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for Newox2.

Pre-market Notification Details

Device IDK945754
510k NumberK945754
Device Name:NEWOX2
ClassificationOximeter
Applicant BCI INTL., INC. W238 N1650 ROCKWOOD DR. Waukesha,  WI  53188
ContactDonald J Alexander
CorrespondentDonald J Alexander
BCI INTL., INC. W238 N1650 ROCKWOOD DR. Waukesha,  WI  53188
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-23
Decision Date1995-07-17

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