PULSE OXIMETER

Oximeter

NONIN MEDICAL, INC.

The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Pulse Oximeter.

Pre-market Notification Details

Device IDK131021
510k NumberK131021
Device Name:PULSE OXIMETER
ClassificationOximeter
Applicant NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth,  MN  55441 -5443
ContactBrodie Pedersen
CorrespondentBrodie Pedersen
NONIN MEDICAL, INC. 13700 1ST AVE. NORTH Plymouth,  MN  55441 -5443
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-12
Decision Date2013-09-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00849686074864 K131021 000
00849686070392 K131021 000

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