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510(k) Data Aggregation
K Number
K173045Device Name
Oximeter
Manufacturer
Date Cleared
2018-06-05
(250 days)
Product Code
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Greatmade Tech limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg at hospital facilities.
Device Description
The SpO2 Sensors are a family of oximeter sensors designed for compatibility with listed predicate oximeter manufacturers/monitors. The sensors are made up of connector, cable, two specific wavelength LEDs & a photo detector assembled into the sensor housing. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The Sensors contain finger clip type, soft tip and textile adhesive type. All the sensors will be labeled for compatibility for a specific monitor.
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