NELLCOR N-20PA PORTABLE PULSE OXIMETER

Oximeter

NELLCOR, INC.

The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Nellcor N-20pa Portable Pulse Oximeter.

Pre-market Notification Details

Device IDK952222
510k NumberK952222
Device Name:NELLCOR N-20PA PORTABLE PULSE OXIMETER
ClassificationOximeter
Applicant NELLCOR, INC. 4280 HACIENDA DR. P.O. BOX 8004 Pleasanton,  CA  94588
ContactDonna Page
CorrespondentDonna Page
NELLCOR, INC. 4280 HACIENDA DR. P.O. BOX 8004 Pleasanton,  CA  94588
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-12
Decision Date1995-08-15

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