AL-800PA PULSE OXIMETER MODULE

Oximeter

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Al-800pa Pulse Oximeter Module.

Pre-market Notification Details

Device IDK884536
510k NumberK884536
Device Name:AL-800PA PULSE OXIMETER MODULE
ClassificationOximeter
Applicant NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine,  CA  92714
ContactMike Dashefsky
CorrespondentMike Dashefsky
NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine,  CA  92714
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-28
Decision Date1989-02-06

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