OQU — Airway Monitoring System Class II
FDA product code OQU covers "Airway Monitoring System", a Class II medical device regulated under 21 CFR 868.5730. Submissions are reviewed by the Anesthesiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OQU
- Device Class
- Class II
- Regulation Number
- 868.5730
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
The device is intended to assist in verifying ett tube placement, assist in detecting ett tube movement and obstruction of the tube tip