KXN — Monitor, Cardiac, Fetal Class II
FDA product code KXN covers "Monitor, Cardiac, Fetal", a Class II medical device regulated under 21 CFR 884.2600. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KXN
- Device Class
- Class II
- Regulation Number
- 884.2600
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No