SENSORMEDICS OXYSHUTTLE II(TM)

Oximeter

SENSORMEDICS CORP.

The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Sensormedics Oxyshuttle Ii(tm).

Pre-market Notification Details

Device IDK913790
510k NumberK913790
Device Name:SENSORMEDICS OXYSHUTTLE II(TM)
ClassificationOximeter
Applicant SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda,  CA  92887 -4645
ContactDavid M Trueblood
CorrespondentDavid M Trueblood
SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda,  CA  92887 -4645
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-23
Decision Date1992-02-26

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