OYS — Patient Bed With Canopy/Restraints Class I
FDA product code OYS covers "Patient Bed With Canopy/Restraints", a Class I medical device regulated under 21 CFR 880.6760. Submissions are reviewed by the General Hospital panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OYS
- Device Class
- Class I
- Regulation Number
- 880.6760
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
Enclosed bed canopy system used as passive restraint.