đź“‹ FDA Reference
Oc-100 Oximeter Interface Calibrator
Telediagnostic Systems
Summary: The oc-100 oximeter interface calibrator by Telediagnostic Systems is a device used to ensure the accuracy of oximeter readings. It is primarily used by clinicians and technicians in settings where precise oxygen saturation measurements are critical.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K884891 ↗
Decision Date ?
December 28, 1988
Product Code ?
DQA
Device Class ?
Class 2
Evidence ?
0 studies
The oc-100 oximeter interface calibrator was cleared through the FDA 510(k) pathway on December 28, 1988. Manufactured by Telediagnostic Systems, it is classified as a Class 2 device under product code DQA.
What It Is
The oc-100 is a calibrator designed to verify and adjust the accuracy of oximeters, which are devices used to measure oxygen saturation in the blood. It works by simulating various oxygen saturation levels, allowing healthcare providers to ensure their oximeters are providing accurate readings. This is crucial in clinical settings where precise monitoring of a patient's oxygen levels is necessary, such as in critical care or during surgical procedures.
FDA-Cleared Indications
- Used to calibrate or verify the accuracy of oximeters.
- Used with oximeter equipment to assess performance across simulated oxygen-saturation levels.
Clinical Applications
- Verification of pulse oximeter accuracy in hospitals and clinics.
- Routine quality assurance and equipment testing by biomedical technicians or clinical engineers.
- Performance checks of oximeters used in critical care, anesthesia, respiratory care, and perioperative settings.
- Testing compatible oximeters before or during clinical use.
Practical Considerations
- Compatibility depends on the oximeter interface and the manufacturer’s operating instructions; users should confirm that the oc-100 supports the specific oximeter model.
- The device simulates oximeter signals rather than measuring a patient’s blood oxygen level and must not be used as a patient monitor.
- Testing should follow the manufacturer’s calibration procedure and the healthcare facility’s equipment-maintenance policy.
- The record describes an electronic calibration device, not an implanted or patient-contact device; body-region, vessel, or MRI-related precautions are generally not applicable.
- The FDA record identifies the device as a Class II product under product code DQA, cleared through the 510(k) pathway in 1988.
Frequently Asked Questions
What is the oc-100 oximeter interface calibrator used for?
It is used to calibrate oximeters, ensuring their accuracy in measuring blood oxygen saturation levels.
What specialties typically use this device?
Specialties such as anesthesiology, pulmonology, and critical care medicine commonly use this device.
What are the FDA-cleared indications?
The device is indicated for calibrating oximeters to ensure accurate oxygen saturation readings in clinical settings.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.