Product code BYL— Anesthesiology
AEROSOL DELIVERY HOOD
- Classification name
- Tent, Oxygen
- Device class
- Class 1
- Regulation
- 21 CFR 868.5700
- Advisory panel
- Anesthesiology
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code BYL
FDA has cleared devices under product code BYL between 1980 and 1994, filed by 9 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1994
- 1991
- 1990
- 1989
- 1988
- 1985
- 1982
- 1980
Top applicants under product code BYL
Recent clearances under product code BYL
- K935126 — NASCOR IGLOO
- K905627 — NASCOR OXYDOME
- K896608 — SPAG PAK
- K895866 — DIRD INGANT O2 (BIO 2 HOOD)
- K893713 — NOVA OXYGEN TENT
- K893714 — KEYSTONE OXYGEN TENT
- K882396 — AEROSOL DELIVERY HOOD
- K851666 — MEDI-COMP NEONATAL OXYGEN HOOD
- K852345 — SEA-LONG NECKSEAL & HOOD
- K820640 — HOO2D SEAT-INFANT
- K802653 — MEDIUM SIZE OXYGEN HOOD #1547
Data sourced from openFDA. This site is unofficial and independent of the FDA.