BYK — Tent, Oxygen, Electrically Powered Class II
FDA product code BYK covers "Tent, Oxygen, Electrically Powered", a Class II medical device regulated under 21 CFR 868.5710. 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
- BYK
- Device Class
- Class II
- Regulation Number
- 868.5710
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No