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K Number
K122927
Device Name
OXICARE FINGERTIP PULSE OXIMETER
Manufacturer
DELBIO INCORPORATED
Date Cleared
2012-12-20

(87 days)

Product Code
DQA,DOA
Regulation Number
870.2700
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The OxiCare Fingertip Pulse Oximeter, model DB11 is indicated for spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult and pediatric patients in hospitals, physician's office, clinical settings and home care environment. The OxiCare Fingertip Pulse Oximeter, model DB11 is not intended for continuous monitoring.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter for the Oxicare Fingertip Pulse Oximeter, Model DB11. It does not contain the detailed acceptance criteria for performance, nor does it describe specific studies that prove the device meets such criteria. This letter primarily confirms the FDA's determination of substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information from this document. The document confirms market clearance but does not elaborate on the technical performance data that led to this clearance.

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).