Product code LBA— Clinical Toxicology
SONICAID MODEL D206E AIR EMBOLI-DETECT
- Classification name
- Procainamide Control Materials
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code LBA
FDA has cleared device under product code LBA, all in 1983, 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 LBA
Recent clearances under product code LBA
Data sourced from openFDA. This site is unofficial and independent of the FDA.