Product code BRW— Anesthesiology
CATCO NEONATAL PALATE GUARD
- Classification name
- Protector, Dental
- Device class
- Class 1
- Regulation
- 21 CFR 868.5820
- Advisory panel
- Anesthesiology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code BRW
FDA has cleared devices under product code BRW between 1985 and 1994, filed by 3 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
- 1985
Top applicants under product code BRW
Recent clearances under product code BRW
Data sourced from openFDA. This site is unofficial and independent of the FDA.