K Number
K010718Device Name
FLEXI-SITE SP02 EAR SENSORManufacturer
Date Cleared
2001-03-23
(11 days)
Product Code
Regulation Number
870.2710Type
SpecialPanel
ANReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 870.2710 Ear oximeter.
(a)
Identification. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.(b)
Classification. Class II (performance standards).