Product code BRX— Anesthesiology
RED DOT 2515 CARDIAC SENSOR SYSTEM
- Classification name
- Stool, Anesthesia
- Device class
- Class 1
- Regulation
- 21 CFR 868.6700
- Advisory panel
- Anesthesiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code BRX
FDA has cleared device under product code BRX, all in 1992, filed by 1 applicant company. 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.
Top applicants under product code BRX
Recent clearances under product code BRX
Data sourced from openFDA. This site is unofficial and independent of the FDA.