BCI 3401 HANDHELD PULSE OXIMETER

Oximeter

BCI INTL., INC.

The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for Bci 3401 Handheld Pulse Oximeter.

Pre-market Notification Details

Device IDK980714
510k NumberK980714
Device Name:BCI 3401 HANDHELD PULSE OXIMETER
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 Received1998-02-24
Decision Date1998-03-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00260720011902 K980714 000
00026072011904 K980714 000

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