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
