Product code ISP— Physical Medicine
ERGOTEST 40 & 45
- Classification name
- Valve, Prosthesis
- Device class
- Class 1
- Regulation
- 21 CFR 890.3420
- Advisory panel
- Physical Medicine
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code ISP
FDA has cleared device under product code ISP, all in 1984, 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 ISP
Recent clearances under product code ISP
Data sourced from openFDA. This site is unofficial and independent of the FDA.