Product code DPN— Clinical Toxicology

HEMOSONIC 200HEMODYNAMIC MONITOR

Classification name
Thin Layer Chromatography, Propoxyphene
Device class
Class 2
Regulation
21 CFR 862.3700
Advisory panel
Clinical Toxicology
Total cleared
1
First cleared
Most recent

Market context for product code DPN

FDA has cleared 1 device under product code DPN, all in 2004, 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.

Top applicants under product code DPN

Recent clearances under product code DPN

Data sourced from openFDA. This site is unofficial and independent of the FDA.