K113215 is an FDA 510(k) clearance for the MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.
Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 14, 2012 after a review of 195 days - an extended review cycle.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.
View all Nonin Medical, Inc. devices
NCT00939224
Completed
Observational
Industry-sponsored
Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization
Calibration and Validation of the a Non-Invasive Regional Oxygen Saturation Device in Neonates, Infants and Children Undergoing Cardiac Catheterization
| Condition studied |
Cardiovascular Disease |
| Eligibility |
All sexes
|
| Principal investigator |
Lori M Mitchell, RN, BSN |
| Sponsor |
Nonin Medical, Inc
(industry)
|
Started 2009-07-01
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Primary completion 2011-08-01
Primary outcome
The success of the validation and calibration will be assessed through the Arms statistic.
Secondary outcome
Tissue (somatic) sensor readings will be described using the descriptive statistics.
Study completed - no results published.
This trial concluded in 2011 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov