Product code KXN— Obstetrics/Gynecology
ABDOMINAL FETAL ECG MODULE
- Classification name
- Monitor, Cardiac, Fetal
- Device class
- Class 2
- Regulation
- 21 CFR 884.2600
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code KXN
FDA has cleared devices under product code KXN between 1976 and 1977, 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
- 1977
- 1976
Top applicants under product code KXN
Recent clearances under product code KXN
Data sourced from openFDA. This site is unofficial and independent of the FDA.