Product code BYK— Anesthesiology
CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT
- Classification name
- Tent, Oxygen, Electrically Powered
- Device class
- Class 2
- Regulation
- 21 CFR 868.5710
- Advisory panel
- Anesthesiology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code BYK
FDA has cleared devices under product code BYK between 1981 and 1995, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1995
- 1988
- 1981
Top applicants under product code BYK
Recent clearances under product code BYK
Data sourced from openFDA. This site is unofficial and independent of the FDA.