CAPNOCHECK II, MODEL 8400

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

BCI INTL., INC.

The following data is part of a premarket notification filed by Bci Intl., Inc. with the FDA for Capnocheck Ii, Model 8400.

Pre-market Notification Details

Device IDK991086
510k NumberK991086
Device Name:CAPNOCHECK II, MODEL 8400
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant BCI INTL., INC. N7 W22025 JOHNSON RD. Waukesha,  WI  53186
ContactDonald Alexander
CorrespondentDonald Alexander
BCI INTL., INC. N7 W22025 JOHNSON RD. Waukesha,  WI  53186
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-31
Decision Date1999-06-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35019517053665 K991086 000
35019517053641 K991086 000
35019517053627 K991086 000
35019315002865 K991086 000
10610586036781 K991086 000
10610586036354 K991086 000
10610586038273 K991086 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.