Product code MPU— Obstetrics/Gynecology
ORALLITE COMPREHENSIVE EXAM TRAY
- Classification name
- Source, Chemiluminescent Light
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code MPU
FDA has cleared devices under product code MPU between 1997 and 2001, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2001
- 1997
Top applicants under product code MPU
Recent clearances under product code MPU
Data sourced from openFDA. This site is unofficial and independent of the FDA.