OXIMETER, IN VIVO CATHETER

Catheter, Oximeter, Fiber-optic

OXIMETRIX, INC.

The following data is part of a premarket notification filed by Oximetrix, Inc. with the FDA for Oximeter, In Vivo Catheter.

Pre-market Notification Details

Device IDK760234
510k NumberK760234
Device Name:OXIMETER, IN VIVO CATHETER
ClassificationCatheter, Oximeter, Fiber-optic
Applicant OXIMETRIX, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDQE  
CFR Regulation Number870.1230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-07-15
Decision Date1976-08-23

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