3420 DIGIT PULSE OXIMETER, MODEL 3420

Oximeter

BCI, INC.

The following data is part of a premarket notification filed by Bci, Inc. with the FDA for 3420 Digit Pulse Oximeter, Model 3420.

Pre-market Notification Details

Device IDK013171
510k NumberK013171
Device Name:3420 DIGIT PULSE OXIMETER, MODEL 3420
ClassificationOximeter
Applicant BCI, INC. N7 W22025 JOHNSON RD. Waukesha,  WI  53186
ContactDonald Alexander
CorrespondentDonald Alexander
BCI, INC. N7 W22025 JOHNSON RD. Waukesha,  WI  53186
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-24
Decision Date2002-01-03
Summary:summary

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