Product code BSE— Anesthesiology
HE TEST
- Classification name
- Analyzer, Gas, Helium, Gaseous-Phase
- Device class
- Class 2
- Regulation
- 21 CFR 868.1640
- Advisory panel
- Anesthesiology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code BSE
FDA has cleared devices under product code BSE between 1984 and 1991, 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
- 1991
- 1984
Top applicants under product code BSE
Recent clearances under product code BSE
Data sourced from openFDA. This site is unofficial and independent of the FDA.