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  CLINIMARK         Clinical Testing & Validation Services for Medical Devices

80 Health Park Dr. Louisville, CO 80027
(+US) 303-926-5432

Pulse Ox Photo

 Pulse OximetryBlood PressureRespiratory RateTemperature Additional ParametersAirway Device Testing Services

Pulse Oximetry

CLINIMARK State-of-the-art Pulse Oximetry Hypoxia (Desaturation) Laboratories provide quick accurate Clinical Trials for Regulatory Submission [FDA 510K, IDE, MDD, etc.] 

CLINIMARK’s laboratory offers Pulse Oximetry Arterial Validation testing (Clinical Trials) using multiple Co-oximeters in each study.  We use both of the most commonly used Co-oximeter brands in our validation studies (Radiometer and Instrumentation Laboratories).  This allows for better matching of the calibration of each pulse oximeter to the Co-oximeter.

[FOR A MORE IN-DEPTH DESCRIPTION OF THIS TEST CLICK HERE]

We conduct the study and provide the raw data for the sponsor to analyze or, if preferred, we will analyze the data and produce an FDA-ready report.

We also provide Remote-Viewing of the Hypoxia Validation study.  It is not necessary to send staff to the Clinimark Labs during a study – We offer live video viewing of tests in progress on your computer. Or you may send your staff to observe or take part in the study.

A hallmark of Clinimark service is confidentiality.  All studies at Clinimark are confidential – we do not make identity of the sponsor-manufacturer public.

CLINIMARK Pulse Oximetry tests meet (and exceed) all Regulatory requirements including:
     · ISO 9919 Medical Electrical Equipment – Particular Requirements for the Basic Safety and Essential    
        Performance of Pulse Oximeter Equipment for Medical Use

     · FDA Reviewer Guidance Document
; Pulse Oximeters – Premarket Notification Submissions, July 19, 2007
     · ISO 14155 Parts 1&2
Clinical Investigation of Medical Devices for Human Subjects

All CLINIMARK studies are registered with the National Institutes of Health (NIH) at ClinicalTrials.Gov

 Pulse Oximerty Regulatory Tests Product Development Testing Hospital Data Collection