DURA-Y OXYGEN TRANSDUCER, EAR CLIP

Oximeter, Ear

NELLCOR, INC.

The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Dura-y Oxygen Transducer, Ear Clip.

Pre-market Notification Details

Device IDK944760
510k NumberK944760
Device Name:DURA-Y OXYGEN TRANSDUCER, EAR CLIP
ClassificationOximeter, Ear
Applicant NELLCOR, INC. 2391 FENTON ST. Chula Vista,  CA  91914 -3511
ContactGerald Palecki
CorrespondentGerald Palecki
NELLCOR, INC. 2391 FENTON ST. Chula Vista,  CA  91914 -3511
Product CodeDPZ  
CFR Regulation Number870.2710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-27
Decision Date1994-10-17

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