Product code DXM— Cardiovascular
CALIBRATOR, DYNAMIC
- Classification name
- Densitometer
- Device class
- Class 2
- Regulation
- 21 CFR 870.1450
- Advisory panel
- Cardiovascular
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code DXM
FDA has cleared devices under product code DXM between 1978 and 1979, filed by 2 applicant companies. 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
- 1979
- 1978
Top applicants under product code DXM
Recent clearances under product code DXM
Data sourced from openFDA. This site is unofficial and independent of the FDA.