TRUSIGNAL SPO2 FINGERTIP SENSOR

Oximeter

GE HEALTHCARE FINLAND OY

The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Trusignal Spo2 Fingertip Sensor.

Pre-market Notification Details

Device IDK101871
510k NumberK101871
Device Name:TRUSIGNAL SPO2 FINGERTIP SENSOR
ClassificationOximeter
Applicant GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki,  FI Fin-00510
ContactTommi Jokiniemi
CorrespondentTommi Jokiniemi
GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki,  FI Fin-00510
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-06
Decision Date2010-10-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682103329 K101871 000
00840682103237 K101871 000

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