CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD

Oximeter

ORIDION CAPNOGRAPHY, INC.

The following data is part of a premarket notification filed by Oridion Capnography, Inc. with the FDA for Capnostream 20p With Masimo Spo2 Board.

Pre-market Notification Details

Device IDK101995
510k NumberK101995
Device Name:CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
ClassificationOximeter
Applicant ORIDION CAPNOGRAPHY, INC. 160 GOULD STREET Needham Heights,  MA  02494
ContactRachel Weissbrod
CorrespondentRachel Weissbrod
ORIDION CAPNOGRAPHY, INC. 160 GOULD STREET Needham Heights,  MA  02494
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-14
Decision Date2011-01-11
Summary:summary

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