U.S. FDA Medical Device Blood Oxygen Partial Pressure Analyzer Requirements: Blood Oxygen Partial Pressure Analyzer
FDA Medical Device Definition: An indwelling blood oxygen partial pressure (PO2) analyzer is a device that consists of a catheter-tip PO2transducer (e.g., PO2electrode) and that is used to measure, in vivo, the partial pressure of oxygen in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status
For more information about Blood Oxygen Partial Pressure Analyzer Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.