Product code IYY— Radiology
GENERATOR, R-WAVE
- Classification name
- Synchronizer, Electrocardiograph, Nuclear
- Device class
- Class 1
- Regulation
- 21 CFR 892.1410
- Advisory panel
- Radiology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code IYY
FDA has cleared devices under product code IYY between 1978 and 1986, 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
- 1986
- 1979
- 1978
Top applicants under product code IYY
Recent clearances under product code IYY
Data sourced from openFDA. This site is unofficial and independent of the FDA.